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Clinical Trial 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.


Clinical Trial 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Breast Neoplasms
  • Breast Neoplasms, Male
  • Carcinoid Tumor
  • Carcinoma
  • Carcinoma, Islet Cell
  • Carcinoma, Merkel Cell
  • Carcinoma, Neuroendocrine
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Endometrial Neoplasms
  • Extensive Stage Small Cell Lung Cancer
  • Gastrointestinal Neoplasms
  • Germinoma
  • Hereditary Paraganglioma
  • Lung Neoplasms
  • Male Breast Cancer
  • Malignant Carcinoid Syndrome
  • Malignant Paraganglioma
  • Metastatic Gastrointestinal Carcinoid Tumor
  • Metastatic Pheochromocytoma
  • Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Neoplasms, Glandular and Epithelial
  • Neuroendocrine Tumors
  • Ovarian Neoplasms
  • Pancreatic Polypeptide Tumor
  • Paraganglioma
  • Pheochromocytoma
  • Prostatic Neoplasms
  • 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
  • Sarcoma
  • Skin Neoplasms
  • Small Cell Lung Carcinoma
  • 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
  • Thyroid Neoplasms
  • Uterine Cervical Neoplasms

NCT number NCT01155258
Study type Interventional
Source University of Southern California
Contact
Status Completed
Phase Phase 1
Start date June 2010
Completion date May 2014

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