Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Irinotecan

Bevacizumab

Fluorouracil

Oxaliplatin

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Cola

Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.

Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor.

5-Fluorouracil

Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study.

Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study.

Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.

Clinical Trials

This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.

A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum

An Expanded Access Program of AvastinTM (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum

An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug.

Duration of survival was defined as the time period from the start of first line therapy to death. Duration of survival was estimated using Kaplan-Meier analysis.

Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions (TL).

Progression-free survival was defined as the duration from the date of starting first-line therapy to the date of documented disease progression or death from any cause. Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Progression-free survival was estimated using Kaplan-Meier analysis.

The best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Progressive disease (PD): at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Complete response (CR): disappearance of all TL and non-TL. If immunocytology was available, no disease was to be detected by that methodology. Partial response (PR): at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Stable disease (SD): neither sufficient shrinkage to qualify for PR or increase to qualify for PD.

Direct medical cost included cost of out-patient consultation and cost of hospitalization.

Hoffmann-La Roche

Participants received IV bevacizumab at a dose of 5 mg/kg q2w in combination with standard of care chemotherapy regimen until disease progression or until termination of the study.

Bevacizumab + Chemotherapy

Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.

Age, Continuous

Sex: Female, Male

Intent-to-treat (ITT) population included all participants receiving at least one dose of study drug.

Medical Communications

Percentage of Participants With Adverse Events

Percentage of Participants Who Died

Duration of Survival

Percentage of Participants With Disease Progression or Death

Progression-Free Survival Time

Missing

Number of Participants With Best Overall Response

Out-Patient Consultation

Hospitalization

ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Number Analyzed = participants who were evaluable for specified categories of this outcome measure.

Mean Direct Medical Cost for Cancer Related Medical Care Utilization

Participants received bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks (q2w) in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.

Spots Global Cancer Trial Database for A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial