Pancreatic CancerPhase 2NCT00882310
A Study of Gemzar, Taxotere, and Xeloda for Adjuvant Pancreatic Cancer
A Phase 2 study testing Gemcitabine, Docetaxel and Capecitabine in people with Pancreatic Cancer, run by Columbia University.
Trial summary
The main purpose of this study will be to evaluate the toxicities as well as the efficacy of a chemotherapy regimen involving the combination of Gemzar, Taxotere, and Xeloda (GTX) in patients with pancreatic cancer, who have undergone complete surgical resection of their tumor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Gemcitabine, Docetaxel and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Oct 2014
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of pancreas that has been completely resected. Patients may be node negative or node-positive, but must have clean margins of resection.
- Ineligible for other high priority national or institutional studies.
- Time from surgical recovery greater than three weeks, but less than six weeks.
- All radiological evaluations (which must include either CT scans of the chest/abdomen/pelvis or a CT of the chest and a MRI of the abdomen/pelvis) must be performed within 4 weeks prior to the start of study therapy.
- Informed Consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
- Non pregnant females who are not breast feeding with a negative serum β-HCG test within 1 week of starting the study. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for 6 months after completion of treatment. They must understand the risks of infertility possibly associated with adjuvant treatment.
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- Clinical Parameters:
- Age ≥ 18 to ≤ 75 years old
- Performance status 0-2 (ECOG)
- Peripheral Neuropathy must be < grade 1
- Able to tolerate oral medications
- Absolute Neutrophil Count > 1,500 ul
- White Blood Count > 3,000/ul
- Platelet count > 100,000/ul
- BUN < 1.5 x ULN
- Creatinine < 1.5 x ULN
- Hemoglobin > 8.0 g/dl
- Serum Albumin > 2.5 mg/dl
- Total Bilirubin < 3.0 mg/dl
- AST ≤4.0 x ULN
- ALT ≤4.0 x ULN
- Alkaline Phosphatase ≤4.0 x ULN]
- CA 19-9 should be normal post surgery. Can still be put on protocol with elevation if clinically significant for inflammation or infection, not cancer
Who cannot join
- Prior chemotherapy for their pancreatic cancer or radiation to the area of the tumor.
- Prior malignancies in last 5 years other than curatively treated carcinoma in-situ of any site in the body.
- Serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
- Patients with compromised immune systems are at increased risk of toxicity and lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients are excluded from the study.
- Any prior investigational agent/therapy or any investigational agent/therapy while on protocol.
- Hypersensitivity: Patients with a history of severe hypersensitivity reaction to Taxotere® or other drug formulated with polysorbate 80 will be excluded.
About this study
Official title: A Phase II Study of Gemzar, Taxotere, and Xeloda (GTX) for Adjuvant Pancreatic Cancer
The main purpose of this study will be to evaluate the toxicities as well as the efficacy of a chemotherapy regimen involving the combination of Gemzar, Taxotere, and Xeloda (GTX) in patients with pancreatic cancer, who have undergone complete surgical resection of their tumor. During the screening evaluation, subjects will have a physical exam and medical history taken by either the PI or a Co investigator. In addition, routine blood tests and radiological exams will be performed, to determine eligibility. Following enrollment, patients will receive 8 cycles (1 cycle = 21 days) of GTX treatment over 6 months. During each cycle patients will receive Gemzar and Taxotere on days 4 and 11, through an IV, over the course of approximately 2 hours, and Xeloda will be taken orally for the first 14 days of every cycle. Patients will receive no treatment on days 15 thru 21 of each cycle. During each cycle of treatment patients will have a physical examination, as well as routine blood work. The first scan will be done prior to initiation of treatment, and the next will be done at completion of chemotherapy. A short quality of life questionnaire will also be administered prior to cycle 1 treatment, at the 3-month point, and at the completion of chemotherapy.
Read the detailed description
The adjuvant treatment of resected pancreatic cancer is currently in flux. Many in the United States continue to use 5FU-based chemotherapy with radiation to the pancreatic bed. Some in the States, and most investigators in Europe, use a 5FU based chemotherapy-alone approach, based on the ESPAC-1 data. Many investigators believe that since gemcitabine is a more active drug in the metastatic setting, it should be moved "up front" in the adjuvant treatment of pancreatic cancer patients. At Columbia, we offer gemcitabine-based treatments with discussions with patients regarding risks, benefits, and limitations in current knowledge. We have usually offered radiation to those with positive margins, and chemotherapy alone to those without. Based on the early studies using gemcitabine, we believe that this will ultimately prove to be a more effective adjuvant drug than 5FU. Some patients have asked for GTX in the adjuvant setting as well, prompting the creation of this trial. Because of concerns about increased toxicity of this regimen, determination of patient safety will be the primary objective of this study, through careful monitoring of adverse events. This trial will be a chemotherapy-only study, offered to those with clean margins of resection.
Taxotere administered "weekly" has activity in a variety of tumor types including breast, lung, ovarian and prostate cancer. Patients with advanced breast cancer, including some who had previously been treated with paclitaxel or anthracyclines, have responded to the weekly administration of Taxotere. The recommended dose of weekly Taxotere is 30-40 mg/m2/week for 6 out of 8 weeks. The same dose intensity can be achieved on a 3 out of 4 week basis. However, this protocol will give drugs 2 out of every 3 weeks, thus dose intensity is less.
Weekly administration of Taxotere is well tolerated and produces substantially less myelosuppression than is observed with standard Taxotere administration every 3 weeks. Acute toxicities are uncommon, as is peripheral neuropathy. Prolonged treatment with weekly Taxotere, may result in chronic toxicities (including, asthenia (fatigue), anemia, edema, excessive lacrimation (epiphora), and onycholysis). Chronic toxicities are most prominent when Taxotere is administered on a continuous weekly basis, i.e., without a break, and are delayed in onset by providing breaks in treatment (for example, treating 6 out of 8 weeks or 3 out of 4 weeks); these chronic toxicities occur at a lower cumulative dose when a continuous weekly schedule of Taxotere is utilized.
Premedication with dexamethasone is recommended for all patients receiving weekly Taxotere therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. A variety of dexamethasone schedules have been used in studies with weekly Taxotere. Dexamethasone 4 to 8 mg x 3 doses taken orally the night before, the morning of, and the evening after Taxotere administration appears to be an effective schedule. We have found that a single low dose of 10 mg IV before the Taxotere usually prevents anaphylaxis and the pedal edema associated with this drug.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine, Docetaxel, Capecitabine
- Keywords
- Pancreatic cancer, Gemzar, Taxotere, Xeloda, GTX
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
Days 4 and 11: gemcitabine 600 mg/m2 over 60 mins intravenous (IV) followed by docetaxel 30 mg/m2 over 60 mins IV
DocetaxelDrug
Also called Taxotere
Days 4 and 11: gemcitabine 600 mg/m2 over 60 mins intravenous (IV) followed by docetaxel 30 mg/m2 over 60 mins IV
CapecitabineDrug
Also called Xeloda
Day 1-14: capecitabine at 1000 mg/m2/day divided into 2 doses given two times a day (BID) by mouth (PO) Maximum dose 2000mg/day divided into BID dosing
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine, Docetaxel, Capecitabine GTX | Experimental | GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months. Receives: Drug: Gemcitabine; Drug: Docetaxel; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Experience Dose Limiting Toxicities (DLTs)
Safety of the GTX regimen in patients with resected pancreatic cancer, using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Data was not analyzed because original PI left institution before data analysis was completed.
Measured: At days 4, 11, and follow-up.
Secondary outcomes (2)
Time to Death
Median recurrence free survival in patients with non-metastatic, resected pancreatic cancer treated with adjuvant GTX.
Data was not analyzed because original PI left institution before data analysis was completed.
Measured: At 6 months (following completion of treatment), and then every 3 months for the first 2 years. After the first 2 year, annually.
Score on FACT-Hep (Version 4)
Quality of life score of patients treated with the adjuvant GTX regimen using, the FACT-Hep (Version 4), a sensitive measure of quality of life.
Data was not analyzed because original PI left institution before data analysis was completed.
Measured: Prior to starting treatment, after 3 months of treatment, and at the end of study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startSep 2006
- Primary completionOct 2014
- Study completionOct 2014
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.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul E Oberstein, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882310
- Sponsor's protocol ID
- AAAB4460
- Status last verified
- Jun 2016
- First submitted
- 23 Mar 2009
- Last updated
- 25 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Gemzar, Taxotere, and Xeloda (GTX) for Adjuvant Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00882310
- Acronym / sponsor ID
- AAAB4460
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, Gemzar, Taxotere, Xeloda, GTX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 16 Apr 2009 (estimated)
- Results
- Posted 22 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study will be to evaluate the toxicities as well as the efficacy of a chemotherapy regimen involving the combination of Gemzar, Taxotere, and Xeloda (GTX) in patients with pancreatic cancer, who have undergone complete surgical resection of their tumor. During the screening evaluation, subjects will have a physical exam and medical history taken by either the PI or a Co investigator. In addition, routine blood tests and radiological exams will be performed, to determine eligibility. Following enrollment, patients will receive 8 cycles (1 cycle = 21 days) of GTX treatment over 6 months. During each cycle patients will receive Gemzar and Taxotere on days 4 and 11, through an IV, over the course of approximately 2 hours, and Xeloda will be taken orally for the first 14 days of every cycle. Patients will receive no treatment on days 15 thru 21 of each cycle. During each cycle of treatment patients will have a physical examination, as well as routine blood work. The first scan will be done prior to initiation of treatment, and the next will be done at completion of chemotherapy. A short quality of life questionnaire will also be administered prior to cycle 1 treatment, at the 3-month point, and at the completion of chemotherapy.
Detailed description
The adjuvant treatment of resected pancreatic cancer is currently in flux. Many in the United States continue to use 5FU-based chemotherapy with radiation to the pancreatic bed. Some in the States, and most investigators in Europe, use a 5FU based chemotherapy-alone approach, based on the ESPAC-1 data. Many investigators believe that since gemcitabine is a more active drug in the metastatic setting, it should be moved "up front" in the adjuvant treatment of pancreatic cancer patients. At Columbia, we offer gemcitabine-based treatments with discussions with patients regarding risks, benefits, and limitations in current knowledge. We have usually offered radiation to those with positive margins, and chemotherapy alone to those without. Based on the early studies using gemcitabine, we believe that this will ultimately prove to be a more effective adjuvant drug than 5FU. Some patients have asked for GTX in the adjuvant setting as well, prompting the creation of this trial. Because of concerns about increased toxicity of this regimen, determination of patient safety will be the primary objective of this study, through careful monitoring of adverse events. This trial will be a chemotherapy-only study, offered to those with clean margins of resection.
Taxotere administered "weekly" has activity in a variety of tumor types including breast, lung, ovarian and prostate cancer. Patients with advanced breast cancer, including some who had previously been treated with paclitaxel or anthracyclines, have responded to the weekly administration of Taxotere. The recommended dose of weekly Taxotere is 30-40 mg/m2/week for 6 out of 8 weeks. The same dose intensity can be achieved on a 3 out of 4 week basis. However, this protocol will give drugs 2 out of every 3 weeks, thus dose intensity is less.
Weekly administration of Taxotere is well tolerated and produces substantially less myelosuppression than is observed with standard Taxotere administration every 3 weeks. Acute toxicities are uncommon, as is peripheral neuropathy. Prolonged treatment with weekly Taxotere, may result in chronic toxicities (including, asthenia (fatigue), anemia, edema, excessive lacrimation (epiphora), and onycholysis). Chronic toxicities are most prominent when Taxotere is administered on a continuous weekly basis, i.e., without a break, and are delayed in onset by providing breaks in treatment (for example, treating 6 out of 8 weeks or 3 out of 4 weeks); these chronic toxicities occur at a lower cumulative dose when a continuous weekly schedule of Taxotere is utilized.
Premedication with dexamethasone is recommended for all patients receiving weekly Taxotere therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. A variety of dexamethasone schedules have been used in studies with weekly Taxotere. Dexamethasone 4 to 8 mg x 3 doses taken orally the night before, the morning of, and the evening after Taxotere administration appears to be an effective schedule. We have found that a single low dose of 10 mg IV before the Taxotere usually prevents anaphylaxis and the pedal edema associated with this drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine, Docetaxel, Capecitabine GTX | Experimental | Drug: Gemcitabine, Drug: Docetaxel, Drug: CapecitabineGTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histologically confirmed adenocarcinoma of pancreas that has been completely resected. Patients may be node negative or node-positive, but must have clean margins of resection.
- Ineligible for other high priority national or institutional studies.
- Time from surgical recovery greater than three weeks, but less than six weeks.
- All radiological evaluations (which must include either CT scans of the chest/abdomen/pelvis or a CT of the chest and a MRI of the abdomen/pelvis) must be performed within 4 weeks prior to the start of study therapy.
- Informed Consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
Key exclusion criteria (6 listed)
- Prior chemotherapy for their pancreatic cancer or radiation to the area of the tumor.
- Prior malignancies in last 5 years other than curatively treated carcinoma in-situ of any site in the body.
- Serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
- Patients with compromised immune systems are at increased risk of toxicity and lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients are excluded from the study.
- Any prior investigational agent/therapy or any investigational agent/therapy while on protocol.
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 |
|---|---|---|
| GemcitabineAlso: GemzarDays 4 and 11: gemcitabine 600 mg/m2 over 60 mins intravenous (IV) followed by docetaxel 30 mg/m2 over 60 mins IV | Drug | Gemcitabine, Docetaxel, Capecitabine GTX |
| DocetaxelAlso: TaxotereDays 4 and 11: gemcitabine 600 mg/m2 over 60 mins intravenous (IV) followed by docetaxel 30 mg/m2 over 60 mins IV | Drug | Gemcitabine, Docetaxel, Capecitabine GTX |
| CapecitabineAlso: XelodaDay 1-14: capecitabine at 1000 mg/m2/day divided into 2 doses given two times a day (BID) by mouth (PO) Maximum dose 2000mg/day divided into BID dosing | Drug | Gemcitabine, Docetaxel, Capecitabine GTX |
Primary outcome
Number of Subjects Who Experience Dose Limiting Toxicities (DLTs)
Time frame: At days 4, 11, and follow-up.
Safety of the GTX regimen in patients with resected pancreatic cancer, using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Data was not analyzed because original PI left institution before data analysis was completed.
2 secondary outcomes
Time to Death
Time frame: At 6 months (following completion of treatment), and then every 3 months for the first 2 years. After the first 2 year, annually.
Score on FACT-Hep (Version 4)
Time frame: Prior to starting treatment, after 3 months of treatment, and at the end of study visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Paul E Oberstein, MD principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Docetaxel and Capecitabine in people with Pancreatic Cancer, run by Columbia University.
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 23 inclusion and 6 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 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 22 Jun 2016). 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?
Number of Subjects Who Experience Dose Limiting Toxicities (DLTs) (time frame: At days 4, 11, and follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2016.