Search / Trial NCT00002828

Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Nov 21, 2003

Trial Information

Current as of November 04, 2024

Completed

Keywords

Stage Iii Colon Cancer Stage Iv Colon Cancer Stage Iii Rectal Cancer Stage Iv Rectal Cancer Recurrent Colon Cancer Recurrent Rectal Cancer

ClinConnect Summary

OBJECTIVES: I. Determine the maximum tolerated dose of raltitrexed when administered with fluorouracil in patients with advanced colorectal carcinoma. II. Determine the toxicity and safety of this regimen in these patients. III. Assess, in a preliminary manner, the antitumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of raltitrexed. Patients receive raltitrexed IV over 15 minutes followed 24 hours later by fluorouracil IV. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients recei...

Gender

ALL

Eligibility criteria

  • DISEASE CHARACTERISTICS: Histologically proven metastatic, locally recurrent, or surgically unresectable colorectal carcinoma Measurable disease No CNS metastasis
  • PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5 times normal (5 times normal if known liver metastases) Renal: Creatinine no greater than 1.5 mg/dL Other: No severe concurrent infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
  • PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1 prior chemotherapy regimen Prior fluorouracil-based regimen for advanced colorectal cancer allowed Prior fluorouracil with radiotherapy not considered therapy for advanced disease At least 4 weeks since prior chemotherapy (8 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy: No concurrent steroids except for antiemesis or as replacement therapy Radiotherapy: See Chemotherapy No prior radiotherapy to more than 30% of bone marrow Surgery: See Disease Characteristics At least 4 weeks since prior surgery unless fully recovered Other: No concurrent vitamin supplements containing folic acid No other concurrent anticancer therapy

About Memorial Sloan Kettering Cancer Center

Memorial Sloan Kettering Cancer Center (MSKCC) is a world-renowned institution dedicated to cancer treatment, research, and education. As a leading clinical trial sponsor, MSKCC focuses on advancing innovative cancer therapies through rigorous scientific investigation and collaboration. The center's multidisciplinary team of experts employs cutting-edge methodologies to design and conduct trials that aim to improve patient outcomes and enhance understanding of cancer biology. With a commitment to translating research findings into clinical practice, MSKCC plays a pivotal role in shaping the future of oncology care and ensuring that patients have access to the latest therapeutic advancements.

Locations

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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