Pemetrexed Disodium and Docetaxel in Treating Patients With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Breast Cancer; Esophageal Cancer; Gastric Cancer; Lung Cancer; Ovarian Cancer; Head and Neck Cancer; Prostate Cancer
• Interventions: Drug: Taxotere (Docetaxel); Drug: Alimta (Pemetrexed)

• Registration Number: NCT01172028
• Lead Sponsor: University of Arizona

Brief 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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-07-28
• Study First Posted: 2010-07-29
• Status Verified: 2014-02
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alimta and Taxotere	Taxotere (Docetaxel)	Alimta and Taxotere given in combination with dose modifications.
Alimta and Taxotere	Alimta (Pemetrexed)	Alimta and Taxotere given in combination with dose modifications.

Primary Outcome Measures

Name	Time	Method
Maximum-tolerated dose (MTD) of combination ALIMTA and Taxotere	From first dose of the study drug until 30 days after the last administration of study medication

Secondary Outcome Measures

Name	Time	Method
Toxicity	From first dose of the study drug until 30 days after the last administration of study medication
Antitumor activity	From first dose of the study drug until 30 days after the last administration of study medication

Trial Locations

Locations (1)

Arizona Cancer Center at University of Arizona Health Sciences Center; 🇺🇸 Tucson, Arizona, United States