Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors

Phase 1

Completed

• Conditions: Recurrent Breast Cancer; Recurrent Cervical Cancer; Recurrent Endometrial Carcinoma; Stage III Neuroendocrine Carcinoma of the Skin; Stage III Ovarian Epithelial Cancer; Stage IV Endometrial Carcinoma; Stage IV Neuroendocrine Carcinoma of the Skin; Stage IV Non-small Cell Lung Cancer; Stage IVA Cervical Cancer; Recurrent Gastrointestinal Carcinoid Tumor
• Interventions: Drug: temsirolimus; Drug: vinorelbine ditartrate

• Registration Number: NCT01155258
• Lead Sponsor: University of Southern California

Brief Summary

RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine ditartrate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus together with vinorelbine ditartrate may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of giving temsirolimus and vinorelbine ditartrate together in treating patients with unresectable or metastatic solid tumors.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the maximal tolerated dose (MTD) for the combination of temsirolimus and vinorelbine in advanced solid tumors.

II. To obtain preliminary information regarding the activity of this combination.

SECONDARY OBJECTIVES:

I. To evaluate the safety and tolerability of this combination.

OUTLINE:

Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and vinorelbine ditartrate IV over 5-10 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-30
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-01
• Primary Completion: 2013-01
• Study Completion: 2014-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-09
• Last Update Posted: 2016-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	temsirolimus	Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and vinorelbine ditartrate IV over 5-10 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm I	vinorelbine ditartrate	Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and vinorelbine ditartrate IV over 5-10 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose of Temsirolimus and Vinorelbine	1 month up to 18 months
To assess the response rate based on the Response Evaluation Criteria in Solid Tumors (RECIST)	2 months up to 18 months

Secondary Outcome Measures

Name	Time	Method
Progression-free and overall survival	Up to 18 months
To evaluate the safety and tolerability of Temsirolimus and Vinorelbine	4 weeks up to 36 weeks

Trial Locations

Locations (1)

USC/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States