A Study of Avastin (Bevacizumab) in Patients With Newly Diagnosed Locally Advanced Rectal Cancer.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00865189
First received: March 18, 2009
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This study will assess the efficacy and safety of two different neoadjuvant trea tment approaches including Avastin in newly diagnosed patients with high risk lo cally advanced rectal cancer. Patients will be randomized into one of two treatm ent arms. Arm A will undergo an induction phase, consisting of 6 cycles of Avast in (5mg/kg iv) plus FOLFOX 4, followed by a 7 week chemoradiation phase, consist ing of Avastin (5mg/kg iv) plus 5-FU plus radiotherapy, followed by surgery. Arm B will omit the induction phase, but will undergo the chemoradiation phase foll owed by surgery. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.


Condition Intervention Phase
Colorectal Cancer
Drug: bevacizumab [Avastin]
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Study to Assess the Effect on Tumor Response, and the Safety, of Two Neo-adjuvant Approaches With Avastin in Newly-diagnosed Patients With High Risk Locally-advanced Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Rate of sterilisation of tumoral specimen: YpT0-N0 [ Time Frame: After surgery (6-8 weeks after chemoradiation) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: Compliance, pathological tumor downstaging rate, recurrence rates, disease free survival, overall survival. Safety: AEs, SAEs, lab parameters, post-operative complications. [ Time Frame: Efficacy:event driven (throughout study)\nSafety:at each clinic visit throughout study ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: November 2007
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
6x2 week cycles of 5mg/kg iv + FOLFOX, followed by 4x2 week cycles of 5mg/kg iv + 5-FU + radiotherapy
Experimental: 2 Drug: bevacizumab [Avastin]
4 x 2 week cycles of 5mg/kg iv + 5-FU + radiotherapy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • histologically confirmed locally advanced rectal cancer;
  • measurable disease;
  • ECOG performance status 0-1;
  • no prior chemotherapy or radiation therapy for rectal cancer.

Exclusion Criteria:

  • prior treatment with Avastin;
  • prior radiotherapy to pelvic region, or previous cytotoxic chemotherapy;
  • previous history of malignancy (other than basal and squamous cell cancer of the skin, or in situ cancer of the cervix);
  • history or evidence of CNS disease;
  • clinically significant cardiovascular disease;
  • chronic treatment with high dose aspirin (>325mg/day) or NSAID.
  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: NCT00865189

Locations
France
Angers, France, 49933
Besancon, France, 25030
Bordeaux, France, 33075
Dijon, France, 21079
La Tronche, France, 38700
Lille, France, 59020
Montbeliard, France, 25209
Montpellier, France, 34928
Nancy, France, 54100
Nice, France, 06189
Paris, France, 75475
Paris, France, 75651
Paris, France, 75970
Pierre Benite, France, 69495
Poitiers, France, 86021
Saint Herblain, France, 44805
Strasbourg, France, 67065
Toulouse, France, 31078
Tours, France, 37044
Vandoeuvre Les Nancy, France, 54511
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00865189     History of Changes
Other Study ID Numbers: ML19202
Study First Received: March 18, 2009
Last Updated: August 4, 2014
Health Authority: France:AFSSAPS

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 25, 2014