AG2037 in Treating Patients With Metastatic Cancer of the Colon or Rectum That Has Not Responded to Fluorouracil and Leucovorin
RATIONALE: AG2037 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well AG2037 works in treating patients with metastatic cancer of the colon or rectum that has progressed or recurred during or after treatment with fluorouracil and leucovorin.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II, Open-Label, Multicenter Study of the GARFT Inhibitor AG2037 in Patients With Metastatic Colorectal Cancer Who Failed Treatment With a 5-Fluorouracil/Leucovorin Regimen|
|Study Start Date:||March 2004|
- Determine the overall objective response rate (complete and partial response) in patients with metastatic adenocarcinoma of the colon or rectum that failed prior fluorouracil and leucovorin calcium therapy and up to 1 other chemotherapy regimen (not including adjuvant chemotherapy) when treated with AG2037.
- Determine time to progression in patients treated with this drug.
- Determine the safety of this drug in these patients.
- Determine the 1-year and overall survival of patients treated with this drug.
- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
- Determine changes in patient outcomes (e.g., symptoms, functioning, and quality of life) in patients treated with this drug.
- Correlate various genetic markers of methylthioadenosine phosphorylase (MTAP), folate, and purine metabolism with clinical response in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study.
Patients receive AG2037 IV over 15-30 minutes on days 1, 8, and 15. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 1 of every course (beginning with course 2), upon exit from the study, and then 30 days after the last treatment dose.
Patients are followed every 3 months for up to 1 year.
PROJECTED ACCRUAL: A total of 23-56 patients will be accrued for this study.
|United States, California|
|Southwest Cancer Care - Poway|
|Poway, California, United States, 92064|
|United States, District of Columbia|
|Lombardi Cancer Center at Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute at University of South Florida|
|Tampa, Florida, United States, 33612-9497|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Ohio|
|Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University|
|Cleveland, Ohio, United States, 44106-5065|
|Principal Investigator:||Leonard B. Saltz, MD||Memorial Sloan-Kettering Cancer Center|
|Principal Investigator:||Ki Y. Chung, MD||Memorial Sloan-Kettering Cancer Center|