Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
|ClinicalTrials.gov Identifier: NCT00004913|
Recruitment Status : Completed
First Posted : March 16, 2004
Last Update Posted : June 1, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: cisplatin Drug: docetaxel Drug: fluorouracil Drug: leucovorin calcium||Phase 1|
OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel administered in combination with cisplatin, fluorouracil, and leucovorin calcium in patients with advanced solid tumors. II. Determine the toxicities associated with this combination regimen in this patient population. III. Evaluate the clinical response to this combination regimen in these patients.
OUTLINE: This is a dose escalation study of docetaxel and fluorouracil (5-FU). Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 2, and leucovorin calcium IV immediately followed by 5-FU IV on days 1-5. Treatment repeats every 3 weeks in the absence of disease progression. Cohorts of 3-5 patients receive escalating doses of docetaxel and 5-FU until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which more than 1 of 3 or 1 of 5 patients experience dose limiting toxicity. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I Study of Docetaxel Plus 5-FU, Cisplatin and Leucovorin in Patients With Advanced Solid Tumors|
|Study Start Date :||January 2000|
|Primary Completion Date :||May 2002|
|Study Completion Date :||May 2002|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004913
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5289|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Study Chair:||Al B. Benson, MD, FACP||Robert H. Lurie Cancer Center|