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
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| ClinicalTrials.gov Identifier: NCT00634725 |
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Recruitment Status :
Completed
First Posted : March 13, 2008
Last Update Posted : December 11, 2015
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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 |
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| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 820 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm 1 (A1) - Gemcitabine
Gemcitabine 2 months, then stop until progression
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Drug: gemcitabine hydrochloride Other: laboratory biomarker analysis |
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Experimental: Arm 2 (B1) Gemcitabine + Erlotinib
B1 Gemcitabine + Erlotinib (100mg/d) 2 months, then erlotinib maintenance (150 mg/d)until progression
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Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride Other: laboratory biomarker analysis |
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Experimental: Arm 3 (A2) CRT
A2 CRT then stop until progression
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Drug: capecitabine Other: laboratory biomarker analysis Radiation: radiation therapy |
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Experimental: Arm 4 (B2) CRT then erlotinib
B2 CRT then erlotinib maintenance (150mg/d) until progression
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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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed adenocarcinoma of the pancreas meeting the following criteria:
- De novo locally advanced disease
- Unresectable disease
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Stage III according to the UICC classification
- No distant metastases
- No localized stage IA-IIB or metastatic stage IV disease according to UICC classification
- Not considered for curative resection after pluridisciplinary discussion
PATIENT CHARACTERISTICS:
Inclusion criteria:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- Polynuclear neutrophils ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin ≥ 9 g/dL
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Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- For patients who have had a recent biliary drain and whose bilirubin is descending, a value of ≤ 3 times ULN is acceptable
- Creatinine ≤ 2 mg/dL
- AST and ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 5 times ULN
- Albumin ≥ 25 g/L
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of therapy
Exclusion criteria:
- Diarrhea ≥ grade 2 and/or uncontrolled diarrhea
- Affiliated with a social security regime
- Unable to follow instructions for psychological, familial, or geographical reasons
- Allergic to one of the ingredients in erlotinib hydrochloride
- Cancer within the past 5 years, except for in situ cancer of the neck of the uterus or basal cell skin cancer
- Severe infection
- Ophthalmic disease (i.e., inflammation, keratopathy, or infection)
- Symptomatic coronary or cardiac insufficiency, myocardial infarction, or stroke within the last 6 months
- Unable to take oral treatments
- Gastrointestinal disorders that could be associated with absorption disorders
- Untreated gastric or duodenal ulcer
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy (including abdominal radiotherapy) or chemotherapy for any reason
- No prior anti-epidermal growth factor-receptor therapy
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
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| Principal Investigator: | Pascal Hammel, MD, PhD | Hopital Beaujon |
| Responsible Party: | GERCOR - Multidisciplinary Oncology Cooperative Group |
| ClinicalTrials.gov Identifier: | NCT00634725 |
| Other Study ID Numbers: |
CDR0000589283 GERCOR-LAP-07-D07-1 EU=20827 ROCHE-GERCOR-LAP-07-D07-1 EudraCT- 2007-001174-81 |
| First Posted: | March 13, 2008 Key Record Dates |
| Last Update Posted: | December 11, 2015 |
| Last Verified: | November 2012 |
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adenocarcinoma of the pancreas stage III pancreatic cancer |
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Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine |
Capecitabine Erlotinib Hydrochloride Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors |