Pancreatic CancerPhase 2NCT01905150
Ph 2 Trial of Vitamin C & G-FLIP (Low Doses Gemcitabine, 5FU, Leucovorin, Irinotecan, Oxaliplatin) for Pancreatic Cancer
A Phase 2 study testing G-FLIP, G-FLIP-DM and Vitamin C in people with Pancreatic Cancer, run by Bruckner Oncology at 1 site in United States.
Trial summary
Pancreatic cancer, especially at advanced metastatic stage, is a devastating disease. It is the fourth leading cause of cancer death. Its prognosis is grim - 5-year survival rate being 6%. The current therapies for advanced metastatic pancreatic cancer are very toxic and with limited efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- G-FLIP, G-FLIP-DM and Vitamin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2014to Jan 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically and cytologically confirmed metastatic (Stage IV), locally advanced unresectable (stage III), or locally recurrent pancreatic adenocarcinoma, with or without prior chemotherapy for their cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status being 0-2.
- Expected survival >3 months.
- Patients 18 years of age and older of both genders.
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 2 weeks prior to treatment initiation.
- Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists.
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- At least 2 weeks must have elapsed from any prior surgery or hormonal therapy.
- Laboratory values ≤2 weeks must be:
- Adequate hematologic
- Adequate hepatic function
- Adequate renal function
- No evidence of active infection and no serious infections within the past month.
- Mentally competent, able to understand and willing to sign the informed consent form.
Who cannot join
- Patients under the age of 18.
- Locally advanced resectable disease from pancreatic cancer
- Previous radiotherapy for cerebral metastases, central nervous system (CNS) or epidural tumor.
- Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any non-cancer indication within the past 4 weeks.
- Patients with any active uncontrolled bleeding, or a bleeding diathesis.
- Pregnant women, or women of child-bearing potential not using reliable means of contraception.
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- Lactating females.
- Fertile men unwilling to practice contraceptive methods during the study period.
- Life expectancy less than 3 months.
- Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients.
- Unwilling or unable to follow protocol requirements.
- Active heart disease including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic myocardial infarction, or symptomatic congestive heart failure.
- Patients with a history of myocardial infarction that is < 3 months prior to registration.
- Patients with any amount of clinically significant pericardial effusion.
- Evidence of active serious infection.
- Patients with known HIV infection.
- Requirement for immediate palliative treatment of any kind including surgery and radiation.
- Patients that have received a chemotherapy regimen requiring stem cell support in the previous 6 months.
- Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ph 2 Trial of G-FLIP (Low Doses Gemcitabine, 5FU, Leucovorin, Irinotecan & Oxaliplatin), Followed by G-FLIP-DM (G-FLIP + Low Doses Docetaxel & MitomycinC), When Used in Combination With Vitamin C, in Patients With Advanced Pancreatic Cancer
Pancreatic cancer, especially at advanced metastatic stage, is a devastating disease. It is the fourth leading cause of cancer death. Its prognosis is grim - 5-year survival rate being 6%. The current therapies for advanced metastatic pancreatic cancer are very toxic and with limited efficacy. A safer and more effective therapy for this devastating disease is greatly needed.
G-FLIP regimen is a combination of low doses (doses lower than those approved by the FDA and used in the clinic) of several anti-cancer drugs, Gemcitabine, Fluorouracil, Leucovorin, Irinotecan and Oxaliplatin. The efficacy of G-FLIP against cancers (especially pancreatic cancer) is based on laboratory and clinical results, which indicates the synergistic efficacy of these anti-cancer drugs against cancer cells and overcoming tumor drug resistance that cancer cells frequently develop. Also, because of their low doses, this regimen is less toxic than when these drugs are used alone.
Meanwhile, intravenous infusion of high doses (doses significantly higher than the daily nutritional requirements) of Vitamin C (ascorbic acid) has been observed to have anti-cancer activities. This is especially true when Vitamin C is used in combination with other anti-cancer drugs.
Read the detailed description
STUDY OBJECTIVE
The objective of this study is to evaluate the safety, tolerability and efficacy of G-FLIP (Low Doses of Gemcitabine, Fluorouracil [5FU], Leucovorin, Irinotecan, and Oxaliplatin), when used in combination with ascorbic acid (Vitamin C), as first-line therapy in patients with advanced pancreatic cancer. The objective of this study is also to evaluate the safety, tolerability and efficacy of G-FLIP-DM (G-FLIP + Low Doses of Docetaxel and Mitomycin C), when used in combination with ascorbic acid, in patients with advanced pancreatic cancer who develop Disease Progression (DP) with G-FLIP treatment. The primary endpoint is 12-month survival rate. The secondary endpoints include Overall Survival (OS), Quality of Life (QOL), Response Rate (RR), Progression-Free-Survival (PFS), and safety.
STUDY DRUGS
Study drugs include G-FLIP, G-FLIP-DM, and Vitamin C (Ascorbic Acid)
STUDY DESIGN
Sample Size:
There will be 34 "evaluable" study subjects in this study.
Treatments:
G-FLIP: All study subjects are treated with G-FLIP. Each treatment cycle of G-FLIP is 2 weeks, with G-FLIP given on Days 1 and 2 of each cycle. If study subjects exhibit Disease Progression (DP), treatment with G-FLIP will stop, and they will be treated with G-FLIP-DM.
G-FLIP-DM: Study subjects who exhibit DP with G-FLIP treatment will be treated with G-FLIP-DM. Each G-FLIP-DM treatment cycle is 2 weeks, with G-FLIP-DM given on Days 1 and 2 of each cycle.
Ascorbic Acid: Ascorbic acid will be administered twice weekly throughout the study, given on any 2 separate days of the week. Ascorbic acid will be administered throughout the study including during the follow-up period, even if treatment with G-FLIP or G-FLIP-DM has been terminated due to DP. Additionally, in 50% of the study subjects (i.e., 15 evaluable study subjects), treatment with ascorbic acid will begin on the same week when G-FLIP begins. In the other 50% of the study subjects (i.e., the other 15 evaluable study subjects), treatment with ascorbic acid will be delayed by 2 cycles. Results from these 2 groups of study subjects would allow comparison of potential acute safety of ascorbic acid, when used in combination with G-FLIP.
Open-Label: This is an open-label study, where investigators and study subjects are not blinded to the treatment.
Randomization: The assignment of study subjects will be randomized, as long as they meet eligibility criteria of the study.
DOSE DELAY AND DOSE MODIFICATION
In the event of adverse drug reactions, dose delay and dose modification will be dependent on the type of toxicities. The detailed dose modification scheme for G-FLIP, G-FLIP-DM and Ascorbic Acid are outlined in the protocol.
CONCOMITANT MEDICATIONS AND PROPHYLACTIC TREATMENT
Other than G-FLIP, G-FLIP-DM and ascorbic acid, patients cannot receive any other standard or investigational treatment for their cancer, or any study drugs for any non-cancer indications, while on this study. All concomitant medications (including names, dosage and schedule) must be recorded.
Prophylactic treatment for drug-related symptoms can be given according to Package Inserts of the study drugs and clinical practice. Supportive treatment may include anti-emetic, anti-diarrhea, anti-pyretic, anti-allergic, anti-hypertensive, analgesics, antibiotics, allopurinol, and others such as blood products and bone marrow growth factors. Patients may use erythropoietin for anemia. The investigator may utilize erythropoietic factors, or blood or platelet transfusions at their discretion.
DURATION OF TREATMENT AND FOLLOW-UP
At least six months of treatment is recommended for study subjects who have a response from G-FLIP or G-FLIP-DM, unless or until:
- Patients exhibit disease progression in the opinion of the principal investigator
- Unacceptable toxicity from the treatment
- Patient withdrawal of consent (Note: The investigator should make every effort to contact the subject to perform a final evaluation and to determine the reason(s) for withdrawal from the study.)
- Investigator's discretion to withdraw patients from the study because continued participation in the study is not in the patient's best interest.
- Underlying illness: a condition, injury, or disease unrelated to the intended disease which the study is investigating, that renders continuing treatment unsafe or regular follow-up impossible
- General or specific changes in the patient's condition that renders the patient ineligible for further investigational treatment
- Non-compliance with investigational treatment, protocol-required evaluations or follow-up visits
After treatment, study subjects should be followed so that information on survival and post study treatment are available for at least 1 year after the study subjects participate in the trial.
EFFICACY ASSESSMENTS
The efficacy of the study drugs will be assessed according to the following parameters:
Response Criteria of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (Disease Progression or DP) will be derived from CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Eisenhauer et al. 2009).
Response Rate (RR) is the number of study subjects, expressed as a percentage of the total number of study subjects participated in the trial, who exhibit PR or CR that has been confirmed from 2 consecutive scans (CT or MRI).
Progression-Free-Survival (PFS) is the length of time when SD (or better) of a study subject is first documented until the time when DP, or death from any cause, occurs.
Overall Survival (OS) is the time from which the study subjects are first treated with G-FLIP to the time when death from any cause occurs. OS, which is the time from which the study subjects are first diagnosed with advanced pancreatic cancer to the time when death from any cause occurs, will also be recorded.
12-Month Survival Rate is the number of study subjects, expressed as a percentage of the total number of study subjects in the trial, who survive for 12 months starting from the time when the study subjects are accrued to the trial. The 12-Month Survival Rate for study subjects who survive for 12 months starting from the time when the study subjects are first diagnosed with advanced pancreatic cancer will also be recorded.
Safety Assessments
The efficacy of the study drugs will be assessed from the first dose to 1 month after last dose of the study drugs. The assessments will be based on the following parameters, performed at baselines and at various times during the study:
- physical exams
- evaluation of symptoms
- vital signs
- ECOG performance status and survival
- clinical pathology (clinical chemistry, renal function [assessed utilizing the Cockcroft-Gault formula], hematology, and coagulation)
- urinalysis
- QOL, assessed as described by Aaronson NK, et al. 1993.
- Conditions
- Pancreatic Cancer
- Being tested
- G-FLIP, G-FLIP-DM, Vitamin C
- Keywords
- pancreatic Cancer, G-FLIP, Gemcitabine 5FU Leucovorin Irinotecan Oxaliplatin, G-FLIP-DM (G-FLIP + Low doses Docetaxel and Mitomycin C), Vitamin C (ascorbic acid)
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-FLIPDrug
Also called Low doses of Gemcitabine, Low dose Fluorouracil [5FU], Leucovorin, Low dose Irinotecan
G-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil [5FU], Leucovorin, Irinotecan, and Oxaliplatin
G-FLIP-DMDrug
Also called Low dose Gemcitabine, Low dose Fluorouracil or 5FU, Leucovorin, Low dose Irinotecan
G-FLIP-DM is low doses of Gemcitabine, Fluorouracil [5FU], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C
Vitamin CDietary supplement
Also called Ascorbic Acid
High dose of Vitamin C, used in combination with G-FLIP and then G-FLIP-DM
| Study group | Role | What they receive |
|---|---|---|
| G-FLIP+VitaminC, then G-FLIP-DM+VitaminC | Experimental | G-FLIP in combination with Vitamin C, then G-FLIP-DM in combination with Vitamin C Receives: Drug: G-FLIP; Drug: G-FLIP-DM; Dietary Supplement: Vitamin C |
| G-FLIP, then G-FLIP-DM | Active comparator | G-FLIP alone, then G-GLIP-DM alone Receives: Drug: G-FLIP; Drug: G-FLIP-DM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Mean months subjects survived.
Measured: Survival was monitored from the first day of treatment until the date of death or last followed up.
Secondary outcomes (1)
Objective Response
Objective Response as a means of efficacy assessment was evaluated in terms of response rate. The response rate assessments included Complete Responses (CR), Partial Responses (PR), Overall Response Rate (ORR), Stable Disease (SD), and Disease Control Rate (DCR). The response rate was according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI. CR was disappearance of all target lesions. PR was >=30% decrease in the sum of the longest diameter of target lesions. ORR was CR + PR. SD was a condition that was not PR or Progressive Disease (PD). Finally, DCR was ORR + SD.
Measured: Performed before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years after the start of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study start13 Aug 2014
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruckner Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Hirschfeld Oncology
- Responsible party
- Sponsor
- Investigators
- Azriel Hirschfeld, MD, Principal investigator, Bruckner Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905150
- Sponsor's protocol ID
- 119005
- Status last verified
- Jan 2020
- First submitted
- 18 Jul 2013
- Last updated
- 11 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bruckner H, Hirschfeld A, Buddaraju S, Stega J, Jahan M, Schwartz ME. Multidisciplinary effect of adding docetaxel and mitomycin-C to low-dose multidrug therapy for cholangiocarcinoma. J Clin Oncol 29: 2011 (suppl; abstr e14546)
Bruckner HW, Myo M, Zaw K, Filipova O, Heidarian S, Rafiq N, Julliard K. Multi-drug chemotherapy for pancreatic cancer. Journal of Clinical Oncology 2005, 23 (16S. June 1 Supplement):4267 (abstract).
Bruckner H, Simon K, Hrehorovich V. Low-dose sequential multi-drug regimens for advanced pancreatic cancer. Journal of Clinical Oncology, 2008, 26 (15S, May 20 Supplement) 15568 (Abstract)
Monti DA, Mitchell E, Bazzan AJ, Littman S, Zabrecky G, Yeo CJ, Pillai MV, Newberg AB, Deshmukh S, Levine M. Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. PLoS One. 2012;7(1):e29794. doi: 10.1371/journal.pone.0029794. Epub 2012 Jan 17.
PubMed 22272248Goel A, Grossbard ML, Malamud S, Homel P, Dietrich M, Rodriguez T, Mirzoyev T, Kozuch P. Pooled efficacy analysis from a phase I-II study of biweekly irinotecan in combination with gemcitabine, 5-fluorouracil, leucovorin and cisplatin in patients with metastatic pancreatic cancer. Anticancer Drugs. 2007 Mar;18(3):263-71. doi: 10.1097/CAD.0b013e3280121334.
PubMed 17264757
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ph 2 Trial of G-FLIP (Low Doses Gemcitabine, 5FU, Leucovorin, Irinotecan & Oxaliplatin), Followed by G-FLIP-DM (G-FLIP + Low Doses Docetaxel & MitomycinC), When Used in Combination With Vitamin C, in Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01905150
- Acronym / sponsor ID
- 119005
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic Cancer, G-FLIP, Gemcitabine 5FU Leucovorin Irinotecan Oxaliplatin, G-FLIP-DM (G-FLIP + Low doses Docetaxel and Mitomycin C), Vitamin C (ascorbic acid)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bruckner OncologyUniversity, hospital or other
- Collaborators
- Hirschfeld Oncology
- Study start
- 13 Aug 2014
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Posted 14 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pancreatic cancer, especially at advanced metastatic stage, is a devastating disease. It is the fourth leading cause of cancer death. Its prognosis is grim - 5-year survival rate being 6%. The current therapies for advanced metastatic pancreatic cancer are very toxic and with limited efficacy. A safer and more effective therapy for this devastating disease is greatly needed.
G-FLIP regimen is a combination of low doses (doses lower than those approved by the FDA and used in the clinic) of several anti-cancer drugs, Gemcitabine, Fluorouracil, Leucovorin, Irinotecan and Oxaliplatin. The efficacy of G-FLIP against cancers (especially pancreatic cancer) is based on laboratory and clinical results, which indicates the synergistic efficacy of these anti-cancer drugs against cancer cells and overcoming tumor drug resistance that cancer cells frequently develop. Also, because of their low doses, this regimen is less toxic than when these drugs are used alone.
Meanwhile, intravenous infusion of high doses (doses significantly higher than the daily nutritional requirements) of Vitamin C (ascorbic acid) has been observed to have anti-cancer activities. This is especially true when Vitamin C is used in combination with other anti-cancer drugs.
Detailed description
STUDY OBJECTIVE
The objective of this study is to evaluate the safety, tolerability and efficacy of G-FLIP (Low Doses of Gemcitabine, Fluorouracil [5FU], Leucovorin, Irinotecan, and Oxaliplatin), when used in combination with ascorbic acid (Vitamin C), as first-line therapy in patients with advanced pancreatic cancer. The objective of this study is also to evaluate the safety, tolerability and efficacy of G-FLIP-DM (G-FLIP + Low Doses of Docetaxel and Mitomycin C), when used in combination with ascorbic acid, in patients with advanced pancreatic cancer who develop Disease Progression (DP) with G-FLIP treatment. The primary endpoint is 12-month survival rate. The secondary endpoints include Overall Survival (OS), Quality of Life (QOL), Response Rate (RR), Progression-Free-Survival (PFS), and safety.
STUDY DRUGS
Study drugs include G-FLIP, G-FLIP-DM, and Vitamin C (Ascorbic Acid)
STUDY DESIGN
Sample Size:
There will be 34 "evaluable" study subjects in this study.
Treatments:
G-FLIP: All study subjects are treated with G-FLIP. Each treatment cycle of G-FLIP is 2 weeks, with G-FLIP given on Days 1 and 2 of each cycle. If study subjects exhibit Disease Progression (DP), treatment with G-FLIP will stop, and they will be treated with G-FLIP-DM.
G-FLIP-DM: Study subjects who exhibit DP with G-FLIP treatment will be treated with G-FLIP-DM. Each G-FLIP-DM treatment cycle is 2 weeks, with G-FLIP-DM given on Days 1 and 2 of each cycle.
Ascorbic Acid: Ascorbic acid will be administered twice weekly throughout the study, given on any 2 separate days of the week. Ascorbic acid will be administered throughout the study including during the follow-up period, even if treatment with G-FLIP or G-FLIP-DM has been terminated due to DP. Additionally, in 50% of the study subjects (i.e., 15 evaluable study subjects), treatment with ascorbic acid will begin on the same week when G-FLIP begins. In the other 50% of the study subjects (i.e., the other 15 evaluable study subjects), treatment with ascorbic acid will be delayed by 2 cycles. Results from these 2 groups of study subjects would allow comparison of potential acute safety of ascorbic acid, when used in combination with G-FLIP.
Open-Label: This is an open-label study, where investigators and study subjects are not blinded to the treatment.
Randomization: The assignment of study subjects will be randomized, as long as they meet eligibility criteria of the study.
DOSE DELAY AND DOSE MODIFICATION
In the event of adverse drug reactions, dose delay and dose modification will be dependent on the type of toxicities. The detailed dose modification scheme for G-FLIP, G-FLIP-DM and Ascorbic Acid are outlined in the protocol.
CONCOMITANT MEDICATIONS AND PROPHYLACTIC TREATMENT
Other than G-FLIP, G-FLIP-DM and ascorbic acid, patients cannot receive any other standard or investigational treatment for their cancer, or any study drugs for any non-cancer indications, while on this study. All concomitant medications (including names, dosage and schedule) must be recorded.
Prophylactic treatment for drug-related symptoms can be given according to Package Inserts of the study drugs and clinical practice. Supportive treatment may include anti-emetic, anti-diarrhea, anti-pyretic, anti-allergic, anti-hypertensive, analgesics, antibiotics, allopurinol, and others such as blood products and bone marrow growth factors. Patients may use erythropoietin for anemia. The investigator may utilize erythropoietic factors, or blood or platelet transfusions at their discretion.
DURATION OF TREATMENT AND FOLLOW-UP
At least six months of treatment is recommended for study subjects who have a response from G-FLIP or G-FLIP-DM, unless or until:
- Patients exhibit disease progression in the opinion of the principal investigator
- Unacceptable toxicity from the treatment
- Patient withdrawal of consent (Note: The investigator should make every effort to contact the subject to perform a final evaluation and to determine the reason(s) for withdrawal from the study.)
- Investigator's discretion to withdraw patients from the study because continued participation in the study is not in the patient's best interest.
- Underlying illness: a condition, injury, or disease unrelated to the intended disease which the study is investigating, that renders continuing treatment unsafe or regular follow-up impossible
- General or specific changes in the patient's condition that renders the patient ineligible for further investigational treatment
- Non-compliance with investigational treatment, protocol-required evaluations or follow-up visits
After treatment, study subjects should be followed so that information on survival and post study treatment are available for at least 1 year after the study subjects participate in the trial.
EFFICACY ASSESSMENTS
The efficacy of the study drugs will be assessed according to the following parameters:
Response Criteria of Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (Disease Progression or DP) will be derived from CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Eisenhauer et al. 2009).
Response Rate (RR) is the number of study subjects, expressed as a percentage of the total number of study subjects participated in the trial, who exhibit PR or CR that has been confirmed from 2 consecutive scans (CT or MRI).
Progression-Free-Survival (PFS) is the length of time when SD (or better) of a study subject is first documented until the time when DP, or death from any cause, occurs.
Overall Survival (OS) is the time from which the study subjects are first treated with G-FLIP to the time when death from any cause occurs. OS, which is the time from which the study subjects are first diagnosed with advanced pancreatic cancer to the time when death from any cause occurs, will also be recorded.
12-Month Survival Rate is the number of study subjects, expressed as a percentage of the total number of study subjects in the trial, who survive for 12 months starting from the time when the study subjects are accrued to the trial. The 12-Month Survival Rate for study subjects who survive for 12 months starting from the time when the study subjects are first diagnosed with advanced pancreatic cancer will also be recorded.
Safety Assessments
The efficacy of the study drugs will be assessed from the first dose to 1 month after last dose of the study drugs. The assessments will be based on the following parameters, performed at baselines and at various times during the study:
- physical exams
- evaluation of symptoms
- vital signs
- ECOG performance status and survival
- clinical pathology (clinical chemistry, renal function [assessed utilizing the Cockcroft-Gault formula], hematology, and coagulation)
- urinalysis
- QOL, assessed as described by Aaronson NK, et al. 1993.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-FLIP+VitaminC, then G-FLIP-DM+VitaminC | Experimental | Drug: G-FLIP, Drug: G-FLIP-DM, Dietary Supplement: Vitamin CG-FLIP in combination with Vitamin C, then G-FLIP-DM in combination with Vitamin C |
| G-FLIP, then G-FLIP-DM | Active comparator | Drug: G-FLIP, Drug: G-FLIP-DMG-FLIP alone, then G-GLIP-DM alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must have histologically and cytologically confirmed metastatic (Stage IV), locally advanced unresectable (stage III), or locally recurrent pancreatic adenocarcinoma, with or without prior chemotherapy for their cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status being 0-2.
- Expected survival >3 months.
- Patients 18 years of age and older of both genders.
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 2 weeks prior to treatment initiation.
Key exclusion criteria (19 listed)
- Patients under the age of 18.
- Locally advanced resectable disease from pancreatic cancer
- Previous radiotherapy for cerebral metastases, central nervous system (CNS) or epidural tumor.
- Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any non-cancer indication within the past 4 weeks.
- Patients with any active uncontrolled bleeding, or a bleeding diathesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-FLIPAlso: Low doses of Gemcitabine, Low dose Fluorouracil [5FU], Leucovorin, Low dose IrinotecanG-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil [5FU], Leucovorin, Irinotecan, and Oxaliplatin | Drug | G-FLIP+VitaminC, then G-FLIP-DM+VitaminC, G-FLIP, then G-FLIP-DM |
| G-FLIP-DMAlso: Low dose Gemcitabine, Low dose Fluorouracil or 5FU, Leucovorin, Low dose IrinotecanG-FLIP-DM is low doses of Gemcitabine, Fluorouracil [5FU], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C | Drug | G-FLIP+VitaminC, then G-FLIP-DM+VitaminC, G-FLIP, then G-FLIP-DM |
| Vitamin CAlso: Ascorbic AcidHigh dose of Vitamin C, used in combination with G-FLIP and then G-FLIP-DM | Dietary supplement | G-FLIP+VitaminC, then G-FLIP-DM+VitaminC |
Primary outcome
Overall Survival
Time frame: Survival was monitored from the first day of treatment until the date of death or last followed up.
Mean months subjects survived.
1 secondary outcome
Objective Response
Time frame: Performed before the start of treatment, at the beginning of each 2-week treatment cycle, at follow-up visit two weeks after completion of treatment, and for up to 3 years after the start of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundBruckner H, Hirschfeld A, Buddaraju S, Stega J, Jahan M, Schwartz ME. Multidisciplinary effect of adding docetaxel and mitomycin-C to low-dose multidrug therapy for cholangiocarcinoma. J Clin Oncol 29: 2011 (suppl; abstr e14546)
- BackgroundBruckner HW, Myo M, Zaw K, Filipova O, Heidarian S, Rafiq N, Julliard K. Multi-drug chemotherapy for pancreatic cancer. Journal of Clinical Oncology 2005, 23 (16S. June 1 Supplement):4267 (abstract).
- BackgroundBruckner H, Simon K, Hrehorovich V. Low-dose sequential multi-drug regimens for advanced pancreatic cancer. Journal of Clinical Oncology, 2008, 26 (15S, May 20 Supplement) 15568 (Abstract)
- Background: PubMed 22272248Monti DA, Mitchell E, Bazzan AJ, Littman S, Zabrecky G, Yeo CJ, Pillai MV, Newberg AB, Deshmukh S, Levine M. Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. PLoS One. 2012;7(1):e29794. doi: 10.1371/journal.pone.0029794. Epub 2012 Jan 17.
- Background: PubMed 17264757Goel A, Grossbard ML, Malamud S, Homel P, Dietrich M, Rodriguez T, Mirzoyev T, Kozuch P. Pooled efficacy analysis from a phase I-II study of biweekly irinotecan in combination with gemcitabine, 5-fluorouracil, leucovorin and cisplatin in patients with metastatic pancreatic cancer. Anticancer Drugs. 2007 Mar;18(3):263-71. doi: 10.1097/CAD.0b013e3280121334.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azriel Hirschfeld, MD principal investigator
Bruckner Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing G-FLIP, G-FLIP-DM and Vitamin C in people with Pancreatic Cancer, run by Bruckner Oncology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Survival was monitored from the first day of treatment until the date of death or last followed up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01905150, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.