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

NCT ID: NCT00399750

Last Updated: 2009-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 373 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2005-06-30

Brief 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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

oxaliplatin

Intervention Type: DRUG

fluoropyrimidine

Intervention Type: DRUG

bevacizumab

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically documented adenocarcinoma of the colon, rectum or appendix.

2. Metastatic/recurrent disease not amenable to potentially curative treatment (e.g., inoperable metastatic disease).

3. 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.

4. ECOG Performance Status 0- 1.

5. 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.

6. Recovery in full from any previous surgical procedure.

7. No other serious concomitant disease.

8. Required baseline laboratory parameters:

1. Absolute neutrophil count (ANC) >/=1,500/mm3 (standard international [SI] units 109/L);

2. Platelets >/= 100,000/mm3 (SI units 109/L);

3. Hemoglobin >/= 8.0 g/dL (SI units mmol/L);

4. Creatinine </= 1.5 x ULN; Total bilirubin </= 2.0 x ULN;

5. Serum glutamate-oxalate transferase (SGOT, AST) Serum glutamic pyruvic transaminase (SGPT, ALT) </= 3 x ULN </= 3 x ULN;

6. Urinalysis - dipstick Protein < +1;

7. Coagulation PT/PTT (INR) Within Normal Limits for Institution;

8. Serum pregnancy test for females of childbearing potential: Negative within 7 calendar days of randomization to study

Exclusion Criteria

The presence of any of the following will exclude a subject from study enrollment:

1. Prior treatment with oxaliplatin or bevacizumab.

2. Any uncontrolled infection.

3. 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.

4. 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.

5. Central nervous system metastases.

6. Peripheral neuropathy of any cause.

7. Pregnant or lactating women.

8. Hypersensitivity to one of the study drugs or ingredients.

9. Participation in any investigational drug study within 4 weeks preceding enrollment.

10. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.

11. Medical or psychiatric disorders that would interfere with informed consent, compliance or make them a poor risk for participation in this trial.

12. Patients with known DPD deficiency.

13. Patients with interstitial pneumonia or extensive symptomatic fibrosis of the lungs.

14. Patients with calculated creatinine clearance of <30 ml/min using Cockroft and Gault formula.

15. Patients who have received an organ allograft.

16. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study entry.

17. Chronic, daily treatment with aspirin (>325 mg/day) or nonsteroidal anti-inflammatory medications (intermittent or "p.r.n." use for pain is permitted).

18. Evidence of a bleeding diathesis or coagulopathy.

19. 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.

20. Patients on chronic therapeutic Warfarin therapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Principal Investigators

Yasir Nagarwala, M.D.

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Bridgewater, New Jersey, United States

Countries

United States

Other Identifiers

L_8851

Identifier Type: -

Identifier Source: org_study_id