Colorectal CancerPhase 4NCT00114946
A Study to Compare Two Avastin-Based Treatment Regimens for the Treatment of Metastatic Colorectal Cancer
A Phase 4 study testing Avastin in people with Colorectal Cancer, run by Genentech, Inc..
Trial summary
This is a randomized, open-label, active-control, multicenter trial comparing two oxaliplatin/Avastin-based treatment sequences as first-line therapy for metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Avastin
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form
- Metastatic or locally advanced and unresectable colorectal cancer
- Measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
- Age >= 18 years
- ECOG performance status of 0 or 1
- Adequate hematologic, hepatic, and renal function at the time of study entry to begin prescribed study therapy, according to institutional guidelines
- Use of an effective form of contraception during the study (for subjects of childbearing potential and their partners)
Who cannot join
- Prior treatment with Avastin
- Hypersensitivity to any of the study drugs or ingredients
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study
- History of any other malignancy (except squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum that has been effectively treated) unless in complete remission and off all therapy for that malignancy for at least 5 years
- Known brain or central nervous system metastases
- Prior treatment for advanced or metastatic colorectal cancer
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- Prior treatment with an anti-angiogenesis agent, in either the adjuvant or metastatic setting
- Concurrent use of investigational anti-neoplastic agents (including up to 4 weeks prior to enrollment)
- Medical or psychiatric disorders that would interfere with informed consent or compliance, or would render the subject at high risk for participation in this study and its follow-up procedures
- Active infection requiring antibiotics on Day 1
- New York Heart Association (NYHA) Grade II or greater CHF
- Evidence of bleeding diathesis or coagulopathy
- Grade > 1 peripheral neuropathy (as defined by the NCI CTCAE, v3.0)
- Lack of physical integrity of the upper gastrointestinal tract or history of malabsorption syndrome
- Blood pressure > 150/100 mmHg
- Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1; anticipation of need for a major surgical procedure during the course of the study
- Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 1
- Urine protein:creatinine ratio >= 1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
- Serious, non-healing wound, ulcer, or bone fracture
- History of myocardial infarction within 6 months prior to Day 1
- Unstable angina
- Clinically significant peripheral vascular disease
- History of stroke within 6 months prior to Day 1
- Pregnancy (positive pregnancy test) or lactation
About this study
Official title: A Randomized, Open-Label Trial Comparing Two Avastin (Bevacizumab)-Based Treatment Regimens for the First-Line Treatment of Metastatic Colorectal Cancer
This is a randomized, open-label, active-control, multicenter trial comparing two oxaliplatin/Avastin-based treatment sequences as first-line therapy for metastatic colorectal cancer. The study is designed to compare the efficacy of these two treatment sequences with respect to progression free survival (PFS) and overall survival.
- Conditions
- Colorectal Cancer
- Being tested
- Avastin
- Keywords
- Metastatic Colorectal Cancer OASIS
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvastinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy, as measured by progression-free survival (PFS), of FOLFOX/Avastin followed by FOLFIRI/Avastin versus FOLFOX/Avastin followed by 5-FU/LV/Avastin as first-line therapy for previously untreated metastatic colorectal cancer.
Secondary outcomes (1)
To evaluate the tolerability of sequential treatment in subjects and to evaluate the safety of an irinotecan/Avastin-based regimen versus a 5-FU/Avastin regimen for previously untreated metastatic colorectal cancer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2005 (estimated)
- Study startMay 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Enrolment
- 800 participants
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mary Sugrue, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114946
- Sponsor's protocol ID
- AVF3430n
- Status last verified
- May 2006
- First submitted
- 20 Jun 2005
- Last updated
- 29 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Trial Comparing Two Avastin (Bevacizumab)-Based Treatment Regimens for the First-Line Treatment of Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00114946
- Acronym / sponsor ID
- AVF3430n
- Conditions
- Colorectal Cancer
- Keywords
- Metastatic Colorectal Cancer OASIS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 800 participants
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Dec 2007
- First posted
- 21 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label, active-control, multicenter trial comparing two oxaliplatin/Avastin-based treatment sequences as first-line therapy for metastatic colorectal cancer. The study is designed to compare the efficacy of these two treatment sequences with respect to progression free survival (PFS) and overall survival.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed Informed Consent Form
- Metastatic or locally advanced and unresectable colorectal cancer
- Measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
- Age >= 18 years
- ECOG performance status of 0 or 1
Key exclusion criteria (25 listed)
- Prior treatment with Avastin
- Hypersensitivity to any of the study drugs or ingredients
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study
- History of any other malignancy (except squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum that has been effectively treated) unless in complete remission and off all therapy for that malignancy for at least 5 years
- Known brain or central nervous system metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avastin | Drug | – |
Primary outcome
To compare the efficacy, as measured by progression-free survival (PFS), of FOLFOX/Avastin followed by FOLFIRI/Avastin versus FOLFOX/Avastin followed by 5-FU/LV/Avastin as first-line therapy for previously untreated metastatic colorectal cancer.
1 secondary outcome
To evaluate the tolerability of sequential treatment in subjects and to evaluate the safety of an irinotecan/Avastin-based regimen versus a 5-FU/Avastin regimen for previously untreated metastatic colorectal cancer.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Sugrue, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Avastin in people with Colorectal Cancer, run by Genentech, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 May 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the efficacy, as measured by progression-free survival (PFS), of FOLFOX/Avastin followed by FOLFIRI/Avastin versus FOLFOX/Avastin followed by 5-FU/LV/Avastin as first-line therapy for previously untreated metastatic colorectal cancer.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2006.