TREE-2: Three Regimens of Eloxatin in Advanced Colorectal Cancer

Completed · Phase 2

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT00399750

Run by

Sanofi

People needed

373

Starts

2002-11-01

Expected to finish

2005-06-01

Last updated by the study team

2009-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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

You may not qualify if…

• 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.
• 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.

Where it is running

• Sanofi-Aventis — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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