NCT01172028

Pemetrexed Disodium and Docetaxel in Treating Patients With Advanced Solid Tumors

Phase I Dose Escalation Trial of Biweekly Alimta (With Vitamin Supplementation) in Combination With Taxotere in Advanced Solid Tumor Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Breast Cancer
• Esophageal Cancer
• Gastric Cancer
• Head and Neck Cancer
• Lung Cancer
• Ovarian Cancer
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Taxotere (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.

Timeline

• Start date: 2005-09-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2010-07-29
• Last updated: 2015-12-03

Locations

1 site across 1 country: United States