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1st Line Chemotherapy Alone or With Bevacizumab in Treating Older Patients With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01417494
First Posted: August 16, 2011
Last Update Posted: May 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive
  Purpose

RATIONALE: Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, 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. Giving bevacizumab together with combination chemotherapy may be a better way to block tumor growth. It is not yet known whether combination chemotherapy is more effective when given together with or without bevacizumab in treating patients with colorectal cancer.

PURPOSE: This randomized phase II trial is studying the side effects of giving bevacizumab together with first-line chemotherapy and to see how well it works in treating older patients with metastatic colorectal cancer.


Condition Intervention Phase
Colorectal Cancer Drug: Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) Drug: Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) + bevacizumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Bevacizumab Combined With First Line Chemotherapy in Patients Aged 75 and Over Suffering From Metastatic Colorectal Adenocarcinoma. Phase II Randomized - Intergroup Trial: FFCD, FNCLCC, GERICO

Resource links provided by NLM:


Further study details as provided by Federation Francophone de Cancerologie Digestive:

Primary Outcome Measures:
  • Efficacy, in terms of objective response or tumoral stability by RECIST criteria [ Time Frame: 4 months ]
  • Deterioration in the Spitzer QoL Index score of ≥ 2 points at baseline and at 4 months [ Time Frame: 4 months ]
  • Tolerance, in terms of no grade 4 arterial hypertension, grade 3-4 thromboembolic event, grade 3-4 cardiac insufficiency, and hospitalization not related to chemotherapy [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: 4 months ]
  • Time to deterioration of autonomy [ Time Frame: 4 months ]
  • Survival with no deterioration of autonomy [ Time Frame: 4 months ]

Enrollment: 102
Study Start Date: July 2011
Study Completion Date: April 2016
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy associated with bevacizumab
Chemotherapy (FOLFIRI, FOLFOX, LV5FU2) associated with bevacizumab
Drug: Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) + bevacizumab
Active Comparator: Chemotherapy
Chemotherapy (FOLFIRI, FOLFOX, LV5FU2)
Drug: Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years to 120 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic colorectal adenocarcinoma

    • Unresectable disease
  • Measurable disease by RECIST criteria
  • No cerebral metastasis

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Polynuclear neutrophils > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Proteinuria ≤ 1 g on 24-hour urine collection
  • No unresolved intestinal occlusion or subocclusion
  • No other progressive or unstabilized malignant tumor within the past 2 years
  • No progressive gastroduodenal ulcer, wound, or bone fracture
  • No active cardiac disease including any of the following:

    • Hypertension not adequately controlled
    • Myocardial infarction within the past 6 months
    • Poorly controlled angina
    • Decompensated congestive cardiac insufficiency
  • No history of arterial thromboembolism or any of the following within the past 12 months:

    • Cerebrovascular accident
    • Transient ischemic attack
    • Subarachnoid hemorrhage
  • No history of distal or visceral ischemic arterial pathology ≥ grade 2 within the past 12 months
  • No history of life-threatening pulmonary embolism within the past 6 months
  • Must have completed the geriatric self-administered questionnaire and the geriatric "team" questionnaire (including the Spitzer QoL Index)

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy for metastatic disease

    • More than 6 months since adjuvant chemotherapy after resection of the primary tumor
  • More than 4 weeks since major surgery, excluding biopsy
  • More than 4 weeks since radiotherapy
  Contacts and Locations
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): NCT01417494


Locations
France
Hôpital Avicenne
Bobigny, France, 93000
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Roche Pharma AG
Investigators
Principal Investigator: Thomas Aparicio Hopital Avicenne
  More Information

Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT01417494     History of Changes
Other Study ID Numbers: CDR0000706869
FFCD-PRODIGE-20 ( Other Identifier: FFCD )
EU-21120 ( Other Identifier: FFCD )
2010-022080-34 ( EudraCT Number )
First Submitted: August 13, 2011
First Posted: August 16, 2011
Last Update Posted: May 30, 2016
Last Verified: May 2016

Keywords provided by Federation Francophone de Cancerologie Digestive:
adenocarcinoma of the colon
stage IVA colon cancer
stage IVB colon cancer
adenocarcinoma of the rectum
stage IVA rectal cancer
stage IVB rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Adenocarcinoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bevacizumab
Oxaliplatin
Fluorouracil
Leucovorin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors