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Trial record 91 of 179 for:    colon cancer | ( Map: New Jersey, United States )

A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00642603
Recruitment Status : Terminated
First Posted : March 25, 2008
Results First Posted : June 23, 2011
Last Update Posted : March 29, 2018
Sponsor:
Information provided by:
Hoffmann-La Roche

Brief Summary:
This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: capecitabine [Xeloda] Drug: bevacizumab [Avastin] Drug: oxaliplatin Drug: irinotecan Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Study of the Effect of First Line Treatment With Xeloda in Combination With Avastin and Either Short Course Irinotecan or Short Course Oxaliplatin on Progression-free Survival in Patients With Metastatic Colorectal Cancer
Study Start Date : May 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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Arm Intervention/treatment
Experimental: XELOX + bevacizumab (Q2W) Drug: capecitabine [Xeloda]
1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle

Drug: bevacizumab [Avastin]
5 mg/kg taken intravenously on Day 1 of each 2 week cycle

Drug: oxaliplatin
85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles

Experimental: XELIRI + bevacizumab (Q2W) Drug: capecitabine [Xeloda]
1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle

Drug: bevacizumab [Avastin]
5 mg/kg taken intravenously on Day 1 of each 2 week cycle

Drug: irinotecan
135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles




Primary Outcome Measures :
  1. Progression-free Survival (PFS) in U.S. Patients Only [ Time Frame: From first patient enrolled up to approximately 48 months ]
    PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, ≥18 years of age
  • Histologically confirmed adenocarcinoma of colon or rectum, with unresectable metastatic or locally advanced disease
  • ≥1 measurable target lesion
  • Ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

Exclusion Criteria:

  • Prior systemic therapy for advanced or metastatic disease
  • History of another malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of the cervix
  • Clinically significant cardiovascular disease
  • Current or recent use of full dose oral warfarin or full dose parenteral anticoagulants or thrombolytic agents
  • Chronic daily treatment with >325 mg/day aspirin

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): NCT00642603


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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

Additional Information:
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Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00642603     History of Changes
Other Study ID Numbers: ML21567
First Posted: March 25, 2008    Key Record Dates
Results First Posted: June 23, 2011
Last Update Posted: March 29, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Capecitabine
Oxaliplatin
Irinotecan
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors