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
This study is ongoing, but not recruiting participants.
Sponsor:
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by (Responsible Party):
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
ClinicalTrials.gov Identifier:
NCT00634725
First received: March 12, 2008
Last updated: November 8, 2012
Last verified: November 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: capecitabine Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride Other: laboratory biomarker analysis Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Drug Information available for:
Gemcitabine
Gemcitabine hydrochloride
Capecitabine
Erlotinib hydrochloride
Erlotinib
U.S. FDA Resources
Further study details as provided by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR):
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]an interim analysis is planned when 196 deaths will be observed
Secondary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
- Relationship between biological markers and survival [ Time Frame: From baseline to death, assessed up to 8 years after the beginning of the study ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 820 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the pancreas meeting the following criteria:
- De novo locally advanced disease
- Unresectable disease
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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634725
Show 72 Study Locations
Show 72 Study LocationsSponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
| Principal Investigator: | Pascal Hammel, MD, PhD | Hopital Beaujon |
More Information
Additional Information:
No publications provided
| Responsible Party: | Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
| ClinicalTrials.gov Identifier: | NCT00634725 History of Changes |
| Other Study ID Numbers: | CDR0000589283, GERCOR-LAP-07-D07-1, EU=20827, ROCHE-GERCOR-LAP-07-D07-1, EudraCT- 2007-001174-81 |
| Study First Received: | March 12, 2008 |
| Last Updated: | November 8, 2012 |
| Health Authority: | France: ANSM - Agence Nationale de sécurité du médicament et des produits de santé (French Competent Authority, previously called AFSSAPS) |
Keywords provided by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR):
|
adenocarcinoma of the pancreas stage III pancreatic cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Capecitabine Erlotinib |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013