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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
ClinicalTrials.gov Identifier:
NCT00265824
First received: December 14, 2005
Last updated: March 20, 2014
Last verified: March 2014
  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 Followed by Maintenance With Bevacizumab Strategy With or Without Erlotinib in Unresectable Metastatic Colorectal Cancer. DREAM OPTIMOX 3. C04-2

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265824

  Show 47 Study Locations
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Study Chair: Aimery de Gramont, MD Hopital Saint Antoine
Study Chair: Christophe Tournigand, MD Hopital Henri Mondor
  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, GERCOR-DREAM- C04-2
Study First Received: December 14, 2005
Last Updated: March 20, 2014
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 July 29, 2014