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

NCT00399750 | Completed Phase 2

• 1 other identifier: L_8851
• Study Type: interventional
• Target: 373
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

Interventions

oxaliplatin DRUG

fluoropyrimidine DRUG

bevacizumab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Oxaliplatin; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yasir Nagarwala, M.D.

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 13, 2006
• First Posted: November 15, 2006
• Study Start: November 1, 2002
• Study Completion: June 1, 2005
• Last Updated: October 15, 2009

Record last verified: 2009-10

Locations

US (1)