Optimized Chemotherapy Followed by Maintenance With Bevacizumab With or Without Erlotinib in Treating Patients With Metastatic Colorectal Cancer That Cannot be Removed by Surgery (DREAM) (DREAM)
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| ClinicalTrials.gov Identifier: NCT00265824 |
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Recruitment Status :
Completed
First Posted : December 15, 2005
Last Update Posted : December 11, 2015
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Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Information provided by (Responsible Party):
GERCOR - Multidisciplinary Oncology Cooperative Group
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Colorectal Cancer | Drug: bevacizumab Drug: bevacizumab, erlotinib | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 700 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase III Study of an Optimized Chemotherapy Followed by Maintenance With Bevacizumab Strategy With or Without Erlotinib in Unresectable Metastatic Colorectal Cancer. DREAM OPTIMOX 3. C04-2 |
| Study Start Date : | May 2005 |
| Actual Primary Completion Date : | March 2012 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| 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 |
Primary Outcome Measures :
- Progression-free survival during maintenance therapy [ Time Frame: Tumor evaluation every 2 months ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
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): NCT00265824
Locations
Show 47 study locations
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Investigators
| Study Chair: | Aimery de Gramont, MD | Hopital Saint Antoine | |
| Study Chair: | Christophe Tournigand, MD | Hopital Henri Mondor |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GERCOR - Multidisciplinary Oncology Cooperative Group |
| ClinicalTrials.gov Identifier: | NCT00265824 |
| Other Study ID Numbers: |
CDR0000453861 GERCOR-C04-2 EU-20565 GERCOR-OPTIMOX3 GERCOR-DREAM- C04-2 |
| First Posted: | December 15, 2005 Key Record Dates |
| Last Update Posted: | December 11, 2015 |
| Last Verified: | March 2014 |
Keywords provided by GERCOR - Multidisciplinary Oncology Cooperative Group:
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stage IV colon cancer stage IV rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum chemotherapy |
Additional relevant MeSH terms:
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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 Hydrochloride Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |