Colorectal CancerPhase 2NCT00399750
TREE-2: Three Regimens of Eloxatin in Advanced Colorectal Cancer
A Phase 2 study testing oxaliplatin, fluoropyrimidine and bevacizumab in people with Colorectal Cancer, run by Sanofi at 1 site in United States.
Trial summary
A randomized, controlled, open-label multicenter trial to assess the safety and efficacy of 3 oxaliplatin-fluoropyrimidine containing regimens (mFOLFOX6; bFOL; XELOX) + Bevacizumab (TREE1 and TREE2) as first line therapy of advanced 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?
- oxaliplatin, fluoropyrimidine and bevacizumab
- How many people
- 373 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Jun 2005
- Phase
- Phase 2
- 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
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Histologically documented adenocarcinoma of the colon, rectum or appendix.
- Metastatic/recurrent disease not amenable to potentially curative treatment (e.g., inoperable metastatic disease).
- No prior chemotherapy for metastatic/recurrent disease. Prior adjuvant treatment with 5-FU/LV and/or IFL is allowed if it is completed at least 6 months before study registration.
- ECOG Performance Status 0- 1.
- At least one unidimensionally measurable lesion with a diameter >/= 20 mm using conventional CT or MRI scans or >/= 10 mm using spiral CT scans. If a single lesion is identified as the target lesion, a histological or cytological confirmation of adenocarcinoma is required.
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- Recovery in full from any previous surgical procedure.
- No other serious concomitant disease.
- Required baseline laboratory parameters:
- Absolute neutrophil count (ANC) >/=1,500/mm3 (standard international [SI] units 109/L);
- Platelets >/= 100,000/mm3 (SI units 109/L);
- Hemoglobin >/= 8.0 g/dL (SI units mmol/L);
- Creatinine </= 1.5 x ULN; Total bilirubin </= 2.0 x ULN;
- Serum glutamate-oxalate transferase (SGOT, AST) Serum glutamic pyruvic transaminase (SGPT, ALT) </= 3 x ULN </= 3 x ULN;
- Urinalysis - dipstick Protein < +1;
- Coagulation PT/PTT (INR) Within Normal Limits for Institution;
- Serum pregnancy test for females of childbearing potential: Negative within 7 calendar days of randomization to study
Who cannot join
- The presence of any of the following will exclude a subject from study enrollment:
- Prior treatment with oxaliplatin or bevacizumab.
- Any uncontrolled infection.
- History of myocardial infarction within the previous 6 months or current clinical evidence of congestive heart failure, non-stable coronary artery disease, clinically significant hypertension (blood pressure of >160/110 mmHg on medication), or symptomatic peripheral vascular disease.
- History of any other cancer (except non melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for that cancer for at least 5 years.
- Central nervous system metastases.
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- Peripheral neuropathy of any cause.
- Pregnant or lactating women.
- Hypersensitivity to one of the study drugs or ingredients.
- Participation in any investigational drug study within 4 weeks preceding enrollment.
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- Medical or psychiatric disorders that would interfere with informed consent, compliance or make them a poor risk for participation in this trial.
- Patients with known DPD deficiency.
- Patients with interstitial pneumonia or extensive symptomatic fibrosis of the lungs.
- Patients with calculated creatinine clearance of <30 ml/min using Cockroft and Gault formula.
- Patients who have received an organ allograft.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study entry.
- Chronic, daily treatment with aspirin (>325 mg/day) or nonsteroidal anti-inflammatory medications (intermittent or "p.r.n." use for pain is permitted).
- Evidence of a bleeding diathesis or coagulopathy.
- Subjects found to have proteinuria at baseline - If patients are found to have >/= 1+ proteinuria at baseline screening they should undergo a 24-hour urine collection, which must be an adequate collection and must demonstrate <2g of protein/24 hr to allow participation in the study.
- Patients on chronic therapeutic Warfarin therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Prospective Study Comparing Three Regimens of Oxaliplatin Plus Fluoropyrimidine and Avastin for Evaluation of Safety and Tolerability in First-line Treatment of Patients With Advanced Colorectal Cancer.
A randomized, controlled, open-label multicenter trial to assess the safety and efficacy of 3 oxaliplatin-fluoropyrimidine containing regimens (mFOLFOX6; bFOL; XELOX) + Bevacizumab (TREE1 and TREE2) as first line therapy of advanced metastatic colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- oxaliplatin, fluoropyrimidine, bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatinDrug
fluoropyrimidineDrug
bevacizumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and efficacy of three oxaliplatin-fluoropyrimidine regimens when combined with bevacizumab as therapy for previously untreated metastatic colorectal cancer (TREE 2)
Secondary outcomes (10)
The overall incidence of grade 3 and grade 4 adverse events during the first 12 weeks of treatment for each of the oxaliplatin-fluoropyrimidine regimens used without bevacizumab (TREE1)
Type, frequency, severity, timing, and relatedness of all adverse events during treatment and for 30 days following discontinuation of treatment for each of the oxaliplatin-fluoropyrimidine regimens when used with or without bevacizumab(TREE1 and TREE2)
Actual treatment administration as characterized by median, mean, and range of doses given; dose modifications, omissions, and delays; and actual and relative dose intensity (TREE1 and TREE2)
Tumor response rate (overall and confirmed) based on application of the Response Evaluation Criteria in Solid Tumors (RECIST) (TREE1 and TREE2)
Time to treatment failure (TTF) (TREE1 and TREE2)
Time to tumor progression (TTP) (TREE1 and TREE2)
Median survival (TREE1 and TREE2)
STUDY DESIGN
A randomized, controlled, open-label multicenter trial to assess the safety & efficacy of 3 oxaliplatin-fluoropyrimidine containing regimens (mFOLFOX6; bFOL; XELOX) +Avastin (TREE1 & TREE2) as first line therapy of advanced metastatic colorectal cancer
Patients enrolled prior to the initiation of Amendment 3 (TREE1) will not be eligible to receive Avastin as a component of their treatment regimen.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startNov 2002
- Study completionJun 2005
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 SanofiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 373 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yasir Nagarwala, M.D., Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399750
- Sponsor's protocol ID
- L_8851
- Status last verified
- Oct 2009
- First submitted
- 13 Nov 2006
- Last updated
- 15 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Study Comparing Three Regimens of Oxaliplatin Plus Fluoropyrimidine and Avastin for Evaluation of Safety and Tolerability in First-line Treatment of Patients With Advanced Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT00399750
- Acronym / sponsor ID
- L_8851
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- Jun 2005
- First posted
- 15 Nov 2006 (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.
A randomized, controlled, open-label multicenter trial to assess the safety and efficacy of 3 oxaliplatin-fluoropyrimidine containing regimens (mFOLFOX6; bFOL; XELOX) + Bevacizumab (TREE1 and TREE2) as first line therapy of advanced metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Histologically documented adenocarcinoma of the colon, rectum or appendix.
- Metastatic/recurrent disease not amenable to potentially curative treatment (e.g., inoperable metastatic disease).
- No prior chemotherapy for metastatic/recurrent disease. Prior adjuvant treatment with 5-FU/LV and/or IFL is allowed if it is completed at least 6 months before study registration.
- ECOG Performance Status 0- 1.
Key exclusion criteria (21 listed)
- Prior treatment with oxaliplatin or bevacizumab.
- Any uncontrolled infection.
- History of myocardial infarction within the previous 6 months or current clinical evidence of congestive heart failure, non-stable coronary artery disease, clinically significant hypertension (blood pressure of >160/110 mmHg on medication), or symptomatic peripheral vascular disease.
- History of any other cancer (except non melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for that cancer for at least 5 years.
- 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 |
|---|---|---|
| oxaliplatin | Drug | – |
| fluoropyrimidine | Drug | – |
| bevacizumab | Drug | – |
Primary outcome
To evaluate the safety and efficacy of three oxaliplatin-fluoropyrimidine regimens when combined with bevacizumab as therapy for previously untreated metastatic colorectal cancer (TREE 2)
10 secondary outcomes
The overall incidence of grade 3 and grade 4 adverse events during the first 12 weeks of treatment for each of the oxaliplatin-fluoropyrimidine regimens used without bevacizumab (TREE1)
Type, frequency, severity, timing, and relatedness of all adverse events during treatment and for 30 days following discontinuation of treatment for each of the oxaliplatin-fluoropyrimidine regimens when used with or without bevacizumab(TREE1 and TREE2)
Actual treatment administration as characterized by median, mean, and range of doses given; dose modifications, omissions, and delays; and actual and relative dose intensity (TREE1 and TREE2)
Tumor response rate (overall and confirmed) based on application of the Response Evaluation Criteria in Solid Tumors (RECIST) (TREE1 and TREE2)
Time to treatment failure (TTF) (TREE1 and TREE2)
Time to tumor progression (TTP) (TREE1 and TREE2)
Median survival (TREE1 and TREE2)
STUDY DESIGN
A randomized, controlled, open-label multicenter trial to assess the safety & efficacy of 3 oxaliplatin-fluoropyrimidine containing regimens (mFOLFOX6; bFOL; XELOX) +Avastin (TREE1 & TREE2) as first line therapy of advanced metastatic colorectal cancer
Patients enrolled prior to the initiation of Amendment 3 (TREE1) will not be eligible to receive Avastin as a component of their treatment regimen.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2009.
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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.
Yasir Nagarwala, M.D. study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oxaliplatin, fluoropyrimidine and bevacizumab in people with Colorectal Cancer, run by Sanofi at 1 site in United States.
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 17 inclusion and 21 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: finished, as of the sponsor's last update on 15 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 evaluate the safety and efficacy of three oxaliplatin-fluoropyrimidine regimens when combined with bevacizumab as therapy for previously untreated metastatic colorectal cancer (TREE 2). 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 15 Oct 2009.