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

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.

Conditions

• Extensive Stage Small Cell Lung Cancer
• Hereditary Paraganglioma
• Male Breast Cancer
• Malignant Paraganglioma
• Metastatic Gastrointestinal Carcinoid Tumor
• Metastatic Pheochromocytoma
• Pancreatic Polypeptide Tumor
• Recurrent Breast Cancer
• Recurrent Cervical Cancer
• Recurrent Endometrial Carcinoma
• Recurrent Gastrointestinal Carcinoid Tumor
• Recurrent Islet Cell Carcinoma
• Recurrent Neuroendocrine Carcinoma of the Skin
• Recurrent Non-small Cell Lung Cancer
• Recurrent Ovarian Epithelial Cancer
• Recurrent Ovarian Germ Cell Tumor
• Recurrent Pheochromocytoma
• Recurrent Prostate Cancer
• Recurrent Renal Cell Cancer
• Recurrent Small Cell Lung Cancer
• Recurrent Uterine Sarcoma
• Regional Gastrointestinal Carcinoid Tumor
• Regional Pheochromocytoma
• Stage III Cervical Cancer
• Stage III Endometrial Carcinoma
• Stage III Neuroendocrine Carcinoma of the Skin
• Stage III Ovarian Epithelial Cancer
• Stage III Ovarian Germ Cell Tumor
• Stage III Prostate Cancer
• Stage III Renal Cell Cancer
• Stage III Uterine Sarcoma
• Stage IIIA Breast Cancer
• Stage IIIA Non-small Cell Lung Cancer
• Stage IIIB Breast Cancer
• Stage IIIB Non-small Cell Lung Cancer
• Stage IIIC Breast Cancer
• Stage IV Breast Cancer
• Stage IV Endometrial Carcinoma
• Stage IV Neuroendocrine Carcinoma of the Skin
• Stage IV Non-small Cell Lung Cancer
• Stage IV Ovarian Epithelial Cancer
• Stage IV Ovarian Germ Cell Tumor
• Stage IV Prostate Cancer
• Stage IV Renal Cell Cancer
• Stage IV Uterine Sarcoma
• Stage IVA Cervical Cancer
• Stage IVB Cervical Cancer
• Thyroid Gland Medullary Carcinoma

Interventions

DRUG

temsirolimus

Given IV

DRUG

vinorelbine ditartrate

Given IV

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

  collaborator INDUSTRY

• University of Southern California

  lead OTHER

Principal Investigators

• Agustin Garcia · University of Southern California

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2013-01-31

Completion

2014-05-31

Countries

• United States

Study Locations