Combination Chemotherapy in Treating Patients With Advanced Cancer
|ClinicalTrials.gov Identifier: NCT00003956|
Recruitment Status : Completed
First Posted : September 14, 2004
Last Update Posted : April 4, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of SCH 66336, fluorouracil, and leucovorin in treating patients who have advanced cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Unspecified Adult Solid Tumor, Protocol Specific||Drug: fluorouracil Drug: leucovorin calcium Drug: lonafarnib||Phase 1|
OBJECTIVES: I. Determine the safety, tolerability, maximum tolerated dose, and dose limiting toxicity of oral SCH 66336 with fluorouracil and leucovorin calcium in patients with advanced malignancy. II. Assess the multiple dose pharmacokinetics of oral SCH 66336 when administered with fluorouracil and leucovorin calcium. III. Assess the pharmacokinetics of fluorouracil when administered with oral SCH 66336. IV. Assess antitumor activity of oral SCH 66336 with fluorouracil and leucovorin calcium in these patients.
OUTLINE: This is a dose escalation study of SCH 66336. Patients receive oral SCH 66336 twice daily for 56 days. Patients receive leucovorin calcium IV over 1-2 minutes immediately followed by fluorouracil IV over 1-2 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SCH 66336. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT) during course 1, with at least 2 patients experiencing DLT at the next higher level.
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Official Title:||A Phase I Study of Continuous Oral Administration of SCH 66336 and 5-Fluorouracil/Leucovorin (5FU/LV) in Patients With Advanced Cancer|
|Study Start Date :||April 1999|
|Actual Primary Completion Date :||January 2001|
|Actual Study Completion Date :||December 2009|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003956
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Leonard B. Saltz, MD||Memorial Sloan Kettering Cancer Center|