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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.

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

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.

Inclusion Criteria

The following information on clinical trials is provided for information purposes only to
allow patients and physicians to have an initial discussion about the trial. This
information is not intended to be complete information about the trial, to contain all
considerations that may be relevant to potential participation in the trial, or to replace
the advice of a personal physician or health professional.


Subjects must meet all of the following inclusion criteria to be eligible for enrollment
into the study:

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

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

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

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

4. Creatinine
5. Serum glutamate-oxalate transferase (SGOT, AST) Serum glutamic pyruvic
transaminase (SGPT, ALT)
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


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

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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)

Principal Investigator

Yasir Nagarwala, M.D.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2002

Completion Date:

June 2005

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms



Sanofi-Aventis Bridgewater, New Jersey  08807