Pancreatic NeoplasmsPhase 2NCT00833859
Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery
A Phase 2 study testing GTX (gemcitabine, docetaxel and capecitabine) and stereotactic body radiation therapy in people with Pancreatic Neoplasms, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at the patient's tumor followed by more chemotherapy can increase the chances that the patient's pancreatic tumor can be removed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- GTX (gemcitabine, docetaxel and capecitabine) and stereotactic body radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Mar 2010
- 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 or cytologically confirmed pancreatic adenocarcinoma that is borderline resectable disease. Borderline resectable lesions are defined as:
- circumferential tumor abutment with the superior mesenteric vein (SMV) or portal vein (PV) or SMV/PV confluence over < 180o.
- circumferential tumor abutment with the superior mesenteric artery (SMA) over < 180o.
- Short segment encasement (360o) of the PV or SMV that is amenable to partial vein resection and reconstruction.
- encasement of the gastroduodenal artery up to the origin of the hepatic artery
- Patients must have measurable disease.
Show all 17Show fewer
- No previous chemotherapy or radiation to the pancreas.
- Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%.
- Patients must have normal organ and marrow function as defined below:
- leukocytes >3,000/μL
- absolute neutrophil count >1,000/μL
- platelets >100,000/μL
- creatinine within normal institutional limits - OR - creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- total bilirubin < institutional upper limit of normal (ULN). Patients may have biliary stents or drains to lower total bilirubin to this range.
- Aspartate Aminotransferase (AST) serum glutamic oxaloacetic transaminase(SGOT) / alanine aminotransferase (ALT) serum glutamic pyruvic transaminase(SGPT) AST and ALT may be up to 2.5 times ULN if alkaline phosphatase < ULN; or alkaline phosphatase may be up to 4 times ULN if AST and ALT are < ULN.
- Has a negative serum or urine pregnancy test within 7 days prior to initiation of therapy (female patients of childbearing potential). Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Patients will agree to continue contraception for 30 days from the date of the last study drug administration.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients with metastatic disease are ineligible. Patients who have had prior chemotherapy for pancreatic adenocarcinoma.
- Patients who have received prior radiation to an abdominal site are not eligible.
- Prior malignancy in the last 3 years, except basal cell carcinoma, squamous cell or in-situ cervical cancer.
- Patients with peripheral neuropathy > grade 2.
- Patients with a history of severe hypersensitivity reaction to Taxotere (docetaxel), other drugs formulated with polysorbate 80, gemcitabine, or capecitabine.
- Patients may not be receiving any other investigational agents.
Show all 11Show fewer
- ECOG PS 3-4
- Pregnant women are excluded from this study because gemcitabine, capecitabine, and docetaxel are Class D agents with the potential for teratogenic or abortifacient effects.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- creatinine clearance < 30 ml/min (Cockcroft-Gault method).
- Patients must not have any comorbid inflammatory conditions of the bowel such as Crohn's Disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase 2 Study of GTX-SRS: Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery for Borderline Resectable Pancreatic Cancer
The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at the patient's tumor followed by more chemotherapy can increase the chances that the patient's pancreatic tumor can be removed completely.
Read the detailed description
- Cycle 1 and 2:
- Days 4, 11 and 25, 32 ....gemcitabine 750 mg/m^2 intravenous piggy back (IVPB) over 30 min
- Days 4, 11 and 25, 32 ....docetaxel 30 mg/m^2 IVPB over 1 hour
- Days 1-14 and 22-35 ....capecitabine 750 mg/m^2 oral twice daily
- Each cycle is 21 days long
- SRS: Day 43 ....25 Gy single fraction to the pancreatic tumor gross target volume
- Cycle 3 and 4:
- Days 54, 61 and 75, 82 ....gemcitabine 750 mg/m^2 IVPB over 30 min
- Days 54, 61 and 75, 82 ....docetaxel 30 mg/m^2 IVPB over 1 hour
- Days 51-64 ....capecitabine 750 mg/m^2 oral twice daily
- Each cycle is 21 days long
- Surgery: Exploratory laparotomy or laparoscopy followed by pancreaticoduodenectomy or central pancreatectomy with or without vein resection and reconstruction as appropriate.
- Conditions
- Pancreatic Neoplasms
- Being tested
- GTX (gemcitabine, docetaxel and capecitabine), stereotactic body radiation therapy
- Keywords
- stereotactic radiosurgery, borderline resectable pancreatic cancer, gastrointestinal, pancreas
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTX (gemcitabine, docetaxel and capecitabine)Drug
Also called Gemcitabine, Taxotere®, docetaxel, Xeloda®
GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14
stereotactic body radiation therapyRadiation
Also called SBRT
stereotactic body radiation therapy (SBRT) 25
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy followed by Radiation Treatment | Experimental | GTX-SRS: Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS) Receives: Drug: GTX (gemcitabine, docetaxel and capecitabine); Radiation: stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Resectability
The intent was to have 33 Evaluable Participants and measure the number of surgical resections with negative margins, ie. R0 resection rate. The new treatment would be of interest if the resectability rate was at least 30%. R0 resections were to be scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin were negative for tumor involvement.
Measured: 6 months per patient
Secondary outcomes (3)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).
Investigators planned to review the occurrences of AEs and SAEs according severity by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0, Acute GI toxicity by Radiation Therapy Oncology Group (RTOG) Gastrointestinal (GI) toxicity scale.
Measured: 6 months per patient
Number of Participants With Objective Response
Investigators planned to prospectively evaluate the ability of serum CA19-9 response and positron-emission tomography (PET) / computed tomography(CT) response to predict pathologic treatment response to GTX-SBRT and to determine the correlation of standardized uptake value (SUV) uptake on PET to fiducial marker placement.
Measured: 6 months per patient
Number of Participants With Overall Survival
We intended to track the number of participants with overall survival at the projected end of the study period. The study was terminated prematurely.
Measured: 6 months per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Abandoned - Lack of funding after only 2 patients enrolled
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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Gregory Springett, M.D., Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833859
- Sponsor's protocol ID
- MCC-15587
- Other IDs
- IST 14091
- Status last verified
- Dec 2013
- First submitted
- 30 Jan 2009
- Last updated
- 9 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of GTX-SRS: Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery for Borderline Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00833859
- Acronym / sponsor ID
- MCC-15587
- Conditions
- Pancreatic Neoplasms
- Keywords
- stereotactic radiosurgery, borderline resectable pancreatic cancer, gastrointestinal, pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Abandoned - Lack of funding after only 2 patients enrolled
- Enrolment
- 2 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 2 Feb 2009 (estimated)
- Results
- Posted 26 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at the patient's tumor followed by more chemotherapy can increase the chances that the patient's pancreatic tumor can be removed completely.
Detailed description
- Cycle 1 and 2:
- Days 4, 11 and 25, 32 ....gemcitabine 750 mg/m^2 intravenous piggy back (IVPB) over 30 min
- Days 4, 11 and 25, 32 ....docetaxel 30 mg/m^2 IVPB over 1 hour
- Days 1-14 and 22-35 ....capecitabine 750 mg/m^2 oral twice daily
- Each cycle is 21 days long
- SRS: Day 43 ....25 Gy single fraction to the pancreatic tumor gross target volume
- Cycle 3 and 4:
- Days 54, 61 and 75, 82 ....gemcitabine 750 mg/m^2 IVPB over 30 min
- Days 54, 61 and 75, 82 ....docetaxel 30 mg/m^2 IVPB over 1 hour
- Days 51-64 ....capecitabine 750 mg/m^2 oral twice daily
- Each cycle is 21 days long
- Surgery: Exploratory laparotomy or laparoscopy followed by pancreaticoduodenectomy or central pancreatectomy with or without vein resection and reconstruction as appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy followed by Radiation Treatment | Experimental | Drug: GTX (gemcitabine, docetaxel and capecitabine), Radiation: stereotactic body radiation therapyGTX-SRS: Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma that is borderline resectable disease. Borderline resectable lesions are defined as:
- Patients must have measurable disease.
- No previous chemotherapy or radiation to the pancreas.
- Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%.
- Patients must have normal organ and marrow function as defined below:
Key exclusion criteria (11 listed)
- Patients with metastatic disease are ineligible. Patients who have had prior chemotherapy for pancreatic adenocarcinoma.
- Patients who have received prior radiation to an abdominal site are not eligible.
- Prior malignancy in the last 3 years, except basal cell carcinoma, squamous cell or in-situ cervical cancer.
- Patients with peripheral neuropathy > grade 2.
- Patients with a history of severe hypersensitivity reaction to Taxotere (docetaxel), other drugs formulated with polysorbate 80, gemcitabine, or capecitabine.
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 |
|---|---|---|
| GTX (gemcitabine, docetaxel and capecitabine)Also: Gemcitabine, Taxotere®, docetaxel, Xeloda®GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14 | Drug | Chemotherapy followed by Radiation Treatment |
| stereotactic body radiation therapyAlso: SBRTstereotactic body radiation therapy (SBRT) 25 | Radiation | Chemotherapy followed by Radiation Treatment |
Primary outcome
Number of Participants With Resectability
Time frame: 6 months per patient
The intent was to have 33 Evaluable Participants and measure the number of surgical resections with negative margins, ie. R0 resection rate. The new treatment would be of interest if the resectability rate was at least 30%. R0 resections were to be scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin were negative for tumor involvement.
3 secondary outcomes
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).
Time frame: 6 months per patient
Number of Participants With Objective Response
Time frame: 6 months per patient
Number of Participants With Overall Survival
Time frame: 6 months per patient
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pancreatic Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Gregory Springett, M.D., Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
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 GTX (gemcitabine, docetaxel and capecitabine) and stereotactic body radiation therapy in people with Pancreatic Neoplasms, run by H. Lee Moffitt Cancer Center and Research Institute 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 17 inclusion and 11 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: stopped early, as of the sponsor's last update on 9 Oct 2017. 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 26 May 2011). 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 Participants With Resectability (time frame: 6 months per patient). 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 9 Oct 2017.