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OpenTrials
Completed

NCT Number: NCT02582970

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chai Yi, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previously untreated metastatic colon or rectal cancer
  • Scheduled to begin IV 5-fluorouracil-based chemotherapy as a first-line treatment

Exclusion criteria

  • Prior chemotherapy for metastatic colon or rectal cancer
  • Planned radiotherapy for underlying disease
  • Central nervous system metastases
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start
  • Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment

Treatment and study plan

5-fluorouracil

Drug

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.

Bevacizumab

Drug

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

Other names: Avastin

Irinotecan

Drug

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

Oxaliplatin

Drug

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

Primary outcomes

  1. Percentage of Participants With Adverse Events

    Time frame: Baseline up to approximately 3 years

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

Secondary outcomes

  1. Percentage of Participants Who Died

    Time frame: Baseline up to approximately 3 years

  2. Duration of Survival

    Time frame: Baseline up to approximately 3 years

    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.

  3. Percentage of Participants With Disease Progression or Death

    Time frame: Baseline up to approximately 3 years

    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).

  4. Progression-Free Survival Time

    Time frame: Baseline up to approximately 3 years

    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.

  5. Number of Participants With Best Overall Response

    Time frame: Baseline up to approximately 3 years

    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.

  6. Mean Direct Medical Cost for Cancer Related Medical Care Utilization

    Time frame: Baseline up to approximately 3 years

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Oct 21, 2015
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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