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Sponsored by: |
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00655499 |
RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving panitumumab together with irinotecan may kill more tumor cells.
PURPOSE: This phase II clinical trial is studying giving panitumumab together with irinotecan to see how well it works as third-line therapy in treating patients with metastatic colorectal cancer.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: irinotecan hydrochloride Drug: panitumumab Procedure: chromogenic in situ hybridization Procedure: fluorescence in situ hybridization Procedure: gene expression analysis Procedure: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | An Open-Label Phase II Clinical Trial of Panitumumab in Combination With Irinotecan for Patients With Advanced Metastatic Colorectal Cancer Without KRAS Mutation (Wild Type) in Third Line Chemotherapy (Patients Pretreated With FOLFOX or XELOX ± Bevacizumab and Irinotecan Alone or FOLFIRI or CAPIRI ± Bevacizumab) [PIMABI] |
Estimated Enrollment: | 68 |
Study Start Date: | January 2008 |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study.
Patients receive panitumumab IV over 30-90 minutes and irinotecan hydrochloride IV over 90 minutes on day 1. Patients who discontinue irinotecan hydrochloride may receive panitumumab monotherapy. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
Archived tumor tissue specimens are obtained at baseline for correlative laboratory studies. Tissue samples are analyzed for EGFR amplification status by chromogenic in situ hybridization and fluorescence in situ hybridization, KRAS and KRAF mutations, and STAT3 expression.
After completion of study therapy, patients are followed at approximately 56 days.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal adenocarcinoma
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior or concurrent anti-EGFR antibody therapy (e.g., cetuximab) or treatment with small molecule EGFR tyrosine kinase inhibitors (e.g., erlotinib hydrochloride)
France | |
Hopital Tenon | Recruiting |
Paris, France, 75970 | |
Contact: Contact Person 33-1-4216-1041 thierry.andre@psl.aphp.fr |
Principal Investigator: | Thierry Andre, MD | Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
Study ID Numbers: | CDR0000593012, GERCOR-PIMABI-C07-1, EUDRACT 2007-004806-28, EU-20836, AMGEN-GERCOR-PIMABI-C07-1 |
Study First Received: | April 9, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00655499 |
Health Authority: | Unspecified |
adenocarcinoma of the colon adenocarcinoma of the rectum stage IV colon cancer |
recurrent rectal cancer stage IV rectal cancer recurrent colon cancer |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Irinotecan Colonic Diseases Bevacizumab Intestinal Diseases Rectal Diseases Camptothecin |
Recurrence Intestinal Neoplasms Rectal neoplasm Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |