Gemcitabine With or Without Capecitabine and/or Radiation Therapy or Gemcitabine With or Without Erlotinib in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00634725|
Recruitment Status : Completed
First Posted : March 13, 2008
Last Update Posted : December 11, 2015
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which regimen of chemotherapy with or without erlotinib and/or radiation therapy is most effective in treating pancreatic cancer.
PURPOSE: This randomized phase III trial is studying giving gemcitabine together with or without capecitabine and/or radiation therapy to see how well it works compared with giving gemcitabine together with or without erlotinib in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: capecitabine Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride Other: laboratory biomarker analysis Radiation: radiation therapy||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||820 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Multicenter Phase III Study in Patients With Locally Advanced Adenocarcinoma of the Pancreas: Gemcitabine With or Without Chemoradiotherapy and With or Without Erlotinib. Intergroup Study|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||September 2014|
Active Comparator: Arm 1 (A1) - Gemcitabine
Gemcitabine 2 months, then stop until progression
|Drug: gemcitabine hydrochloride Other: laboratory biomarker analysis|
Experimental: Arm 2 (B1) Gemcitabine + Erlotinib
B1 Gemcitabine + Erlotinib (100mg/d) 2 months, then erlotinib maintenance (150 mg/d)until progression
|Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride Other: laboratory biomarker analysis|
Experimental: Arm 3 (A2) CRT
A2 CRT then stop until progression
|Drug: capecitabine Other: laboratory biomarker analysis Radiation: radiation therapy|
Experimental: Arm 4 (B2) CRT then erlotinib
B2 CRT then erlotinib maintenance (150mg/d) until progression
|Drug: capecitabine Drug: erlotinib hydrochloride Other: laboratory biomarker analysis Radiation: radiation therapy|
- Overall survival [ Time Frame: from the date of the first randomization to the date of patient death,due to any cause, or to the last date the patient was known to be alive, assessed up to 8 years after the beginning of the study ]an interim analysis is planned when 196 deaths will be observed
- Progression-free survival [ Time Frame: time from the date of the first randomization to the date of progressive disease or death, assessed up to 8 years after the beginning of the study. ]
- Relationship between biological markers and survival [ Time Frame: From baseline to death, assessed up to 8 years after the beginning of the study ]1 biopsy/patient of the pancreas before treatment
- tolerance to erlotinib [ Time Frame: from start of treatment until the event has resolved or stabilized or until death ]
To evaluate tolerance to erlotinib as maintenance treatment after the end of CT or CRT.
During each visit, any adverse events will be noted and graded according to version 3 of the NCI-CTCAE. Any adverse events that persist at the end of the CTI will be followed up until they disappear.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634725
Show 72 Study Locations
|Principal Investigator:||Pascal Hammel, MD, PhD||Hopital Beaujon|