RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have recurrent metastatic colorectal cancer.

Condition	Treatment or Intervention	Phase
recurrent colon cancer Stage IV rectal cancer recurrent rectal cancer stage IV colon cancer	Procedure: chemotherapy  Drug: oxaliplatin	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the overall response rate, onset and duration of partial and complete responses, and duration of stable disease in patients with recurrent metastatic colorectal cancer treated with oxaliplatin. II. Determine the overall survival of patients treated with this drug. III. Determine the proportion of patients with tumor-related symptomatic improvement and time to tumor-related symptomatic worsening in patients treated with this drug. IV. Determine the time to disease progression in patients treated with this drug. V. Determine the proportion of patients achieving stable disease when treated with this drug. VI. Determine the safety of this drug in this patient population.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive oxaliplatin IV over 120 minutes on day 1. Treatment repeats every 3 weeks for up to 1 year in the absence of disease progression. Patients are followed at 30 days after the last treatment and then every 8 weeks for 10 months.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed recurrent metastatic adenocarcinoma of the colon or rectum; Not amenable to potentially curative treatment (e.g., inoperable metastatic disease)
• Progressive disease following first-line and second-line treatment for metastatic disease; Documented by CT or MRI scan
• At least 1 unidimensionally measurable lesion; At least 20 mm by CT or MRI scan; At least 10 mm by spiral CT scan

--Prior/Concurrent Therapy--

• Biologic therapy: No prior biologic therapy
• Chemotherapy: First-line therapy with bolus fluorouracil and leucovorin calcium required; Second-line therapy with irinotecan required; At least 3 weeks since prior irinotecan and recovered; No other prior chemotherapy for metastatic disease; No prior oxaliplatin
• Endocrine therapy: Not specified
• Radiotherapy: At least 3 weeks since prior radiotherapy; No prior radiotherapy to target lesions unless documented disease progression within the radiation portal
• Surgery: See Disease Characteristics; More than 4 weeks since prior surgery for primary or metastatic disease and recovered
• Other: No other concurrent investigational agents

--Patient Characteristics--

• Age: 18 and over
• Performance status: Karnofsky 50-100%
• Life expectancy: Not specified
• Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT and SGPT no greater than 2 times ULN (5 times ULN if liver metastases present); Alkaline phosphatase no greater than 2 times ULN (3 times ULN if liver metastases present)
• Renal: Creatinine no greater than 1.5 times ULN
• Cardiovascular: No unstable angina; No myocardial infarction within the past 6 months; No New York Heart Association class III or IV symptomatic congestive heart failure; No serious cardiac arrhythmia
• Pulmonary: No interstitial pneumonia or extensive and symptomatic fibrosis of the lung
• Other: No history of intolerance to antiemetics (e.g., 5-HT3 antagonists) or antidiarrheal medication (e.g., loperamide) to be administered concurrently with study chemotherapy; No history of allergies to drugs containing platinum; No known concurrent peripheral neuropathy; No diabetes; No active infection; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 6 months after study

District of Columbia
      Washington Cancer Institute, Washington,  District of Columbia,  20010,  United States
Florida
      Comprehensive Cancer Care Specialists of Boca Raton, Boca Raton,  Florida,  33428,  United States
Kentucky
      Kentuckiana Cancer Institute, Louisville,  Kentucky,  40202,  United States
Nebraska
      University of Nebraska Medical Center, Omaha,  Nebraska,  68198-3330,  United States
New York
      Veterans Affairs Medical Center - Albany, Albany,  New York,  12208,  United States
North Carolina
      Raleigh Hematology/Oncology Associates - Wake Practice, Raleigh,  North Carolina,  27609,  United States
      Southeastern Medical Oncology Center, Goldsboro,  North Carolina,  27534,  United States
Pennsylvania
      Pinnacle Health Hospitals, Harrisburg,  Pennsylvania,  17105-8700,  United States
      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104-4283,  United States
Tennessee
      Memphis Cancer Center, Memphis,  Tennessee,  38119,  United States

Study chairs or principal investigators

Richard Alan Gams,  Study Chair,  Prologue Research International   

Study ID Numbers:  CDR0000068647; PROLOGUE-EFC4759; SANOFI-EFC4759
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  June 6, 2001
ClinicalTrials.gov Identifier:  NCT00017082
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08