Combination Chemotherapy and Bevacizumab With or Without Erlotinib in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
This study has been completed.
Sponsor:
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by (Responsible Party):
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
ClinicalTrials.gov Identifier:
NCT00265824
First received: December 14, 2005
Last updated: May 21, 2012
Last verified: May 2012
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Purpose
PURPOSE: This randomized phase III trial is studying maintenance therapy with bevacizumab alone after an induction therapy combining bevacizumab+chemotherapy to see how well they work compared to maintenance therapy with bevacizumab+erlotinib alone after an induction therapy combining bevacizumab+chemotherapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: bevacizumab Drug: bevacizumab, erlotinib |
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: | Phase III Study of an Optimized Chemotherapy + Avastin Strategy ± Tarceva in Metastatic Colorectal Cancer |
Resource links provided by NLM:
Further study details as provided by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR):
Primary Outcome Measures:
- Progression-free survival during maintenance therapy [ Time Frame: Tumor evaluation every 2 months ] [ Designated as safety issue: No ]
| Enrollment: | 700 |
| Study Start Date: | May 2005 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: bevacizumab alone |
Drug: bevacizumab
bevacizumab 7.5mg/kg every 3 weeks until disease progression or limiting toxicity
|
| Experimental: Bevacizumab + erlotinib |
Drug: bevacizumab, erlotinib
bevacizumab 7.5mg/kg and oral erlotinib 150 mg/day continuously Cycles every 3 weeks until disease progression or limiting toxicity
|
Detailed Description:
OBJECTIVES:
Primary
- Compare Progression-free survival during maintenance period ("Maintenance PFS")in patients with unresectable metastatic colorectal cancer.
Secondary
- Compare the duration of disease control and overall survival of patients treated with these regimens.
- Compare the tolerability of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the occurrence of secondary surgery in patients treated with these regimens.
- Compare the chemotherapy-free intervals and response rates in patients treated with these regimens.
INDUCTION THERAPY
Bevacizumab IV over 30-90 minutes on day 1, combined with either:
- modified FOLFOX7 (IV : oxaliplatin, folinic acid, fluorouracil),
- XELOX2 (IV : oxaliplatin, oral capecitabine day 1 to 8),
- FOLFIRI (IV : irinotecan, folinic acid, fluorouracil).
Treatment repeats every 2 weeks.
RANDOMIZATION Patients with stable or responding disease then receive maintenance therapy with bevacizumab alone or bevacizumab+erlotinib
MAINTENANCE THERAPY
- Arm A : bevacizumab alone : bevacizumab IV over 30-90 minutes on day 1
- Arm B : bevacizumab+erlotinib : bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib once daily on days 1-21.
In both arms, treatment with bevacizumab +/- erlotinib repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
ACCRUAL: A total of 700 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
MAIN ELIGIBILITY CRITERIA
- Histologically proven metastatic adenocarcinoma of colon or rectum
- Documented inoperable disease (i.e., not suitable for complete carcinological surgical resection)
- Measurable lesion as assessed by CT scan or MRI in at least one dimension (longest diameter to be recorded) ≥ 20 mm with conventional CT scan or ≥ 10 mm with spiral CT scan
- No previous therapy for metastatic disease
- No history or evidence upon physical examination of CNS disease (e.g., non-irradiated CNS metastasis, seizure not controlled with standard medical therapy, or history of stroke) unless adequately treated
- No exclusive bone metastasis
- ECOG performance status 0-2
- WBC ≥ 1,500/mm^3
- Platelets ≥ 100,000/mm^3
- Hemoglobin > 9 g/dL (may be transfused to maintain or exceed this level)
- Proteinuria < 2+ by dipstick OR ≤ 1 g of protein on 24-hr urine collection
- Bilirubin < 1.5 times ULN
- Alkaline phosphatase < 3 times ULN
- No peripheral sensory neuropathy
- Negative pregnancy test
- Fertile patients must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterilization)
- No peripheral neuropathy ≥ grade 1
- No clinically significant (i.e. active) cardiovascular disease
- No evidence of bleeding diathesis or coagulopathy
- No serious, non-healing wound, ulcer, or bone fracture
- No significant ophthalmologic abnormality
- More than 28 days since prior major surgical procedure or open biopsy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265824
Locations
| France | |
| Institut Sainte Catherine | |
| Avignon, France, 84000 | |
| Hopital Drevon | |
| Dijon, France, 21000 | |
| Clinique Victor Hugo | |
| Le Mans, France, F-72000 | |
| Hopital Robert Boulin | |
| Libourne, France, 33500 | |
| Clinique Saint Jean | |
| Lyon, France, 69008 | |
| Centre Hospitalier Intercommunal Le Raincy - Montfermeil | |
| Montfermeil, France, 93370 | |
| Hopital Europeen Georges Pompidou | |
| Paris, France, 75015 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Polyclinique De Courlancy | |
| Reims, France, F-51100 | |
| C.H. Senlis | |
| Senlis, France, 60309 | |
| Hopital Foch | |
| Suresnes, France, 92151 | |
| Institut Claudius Regaud | |
| Toulouse, France, 31052 | |
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
| Study Chair: | Aimery de Gramont, MD | Hopital Saint Antoine |
| Study Chair: | Christophe Tournigand | Hopital Saint Antoine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
| ClinicalTrials.gov Identifier: | NCT00265824 History of Changes |
| Other Study ID Numbers: | CDR0000453861, GERCOR-C04-2, EU-20565, GERCOR-OPTIMOX3-TARCEVA, ROCHE-GERCOR-C04-2, GERCOR-DREAM- C04-2 |
| Study First Received: | December 14, 2005 |
| Last Updated: | May 21, 2012 |
| Health Authority: | France : Agence Française de Sécurité Sanitaire et Produits de Santé (AFSSAPS) |
Keywords provided by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR):
|
stage IV colon cancer stage IV rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum chemotherapy |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Bevacizumab |
Erlotinib Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013