Pemetrexed Disodium and Docetaxel in Treating Patients With Advanced Solid Tumors
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells of by stopping them from dividing. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of giving pemetrexed disodium and docetaxel together in treating patients with advanced solid tumors.
Head and Neck Cancer
Drug: Texotere (Docetaxel)
Drug: Alimta (Pemetrexed)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Dose Escalation Trial of Biweekly Alimta (With Vitamin Supplementation) in Combination With Taxotere in Advanced Solid Tumor Patients|
- Maximum-tolerated dose (MTD) of combination ALIMTA and Taxotere [ Time Frame: From first dose of the study drug until 30 days after the last administration of study medication ] [ Designated as safety issue: Yes ]
- Toxicity [ Time Frame: From first dose of the study drug until 30 days after the last administration of study medication ] [ Designated as safety issue: Yes ]
- Antitumor activity [ Time Frame: From first dose of the study drug until 30 days after the last administration of study medication ] [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Drug: Texotere (Docetaxel)
Taxotere is a third generation cytotoxic chemotherapy agent which is a semisynthetic taxane that inhibits cell division by promoting the rate of microtubule assembly and preventing microtubule depolymerization. It has broad antitumor activity in a range of solid tumors, and has been studied on a weekly as well as a biweekly dosing schedule.Drug: Alimta (Pemetrexed)
ALIMTA is a novel antifolate drug with three enzyme targets in the purine and pyrimidine synthetic pathway. It has broad activity in solid tumors and has been combined with a number of other chemotherapy agents. Its toxicity is modified by the use of continuous vitamin supplementation.
- To determine the maximum-tolerated dose of the combination of pemetrexed disodium and docetaxel when administered on a day 1 and day 15 dosing schedule.
- To specifically characterize the toxicity profile for the combination of biweekly pemetrexed disodium and docetaxel.
- To investigate the antitumor activity in patients with advanced solid tumors as measured by RECIST criteria for patients with measurable disease or tumor markers for patients with non-measurable disease.
- To determine the recommended phase II dose of the combination of pemetrexed disodium and docetaxel on a biweekly dosing schedule.
OUTLINE: This is a dose-escalation study.
Patients receive pemetrexed disodium IV over 10 minutes and docetaxel IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172028
|United States, Arizona|
|Arizona Cancer Center at University of Arizona Health Sciences Center|
|Tucson, Arizona, United States, 85724-5024|
|Principal Investigator:||Lee Cranmer, MD, PhD||University of Arizona|