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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01155258
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : June 13, 2016
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
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 Drug: temsirolimus Drug: vinorelbine ditartrate Phase 1

Detailed Description:


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.


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


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Clinical Trial of Temsirolimus and Vinorelbine in Advanced Solid Tumors.
Study Start Date : June 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: Arm I
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.
Drug: temsirolimus
Given IV
Other Names:
  • CCI-779
  • cell cycle inhibitor 779
  • rapamycin analog CCI-779
  • Torisel

Drug: vinorelbine ditartrate
Given IV
Other Names:
  • Biovelbin
  • Eunades
  • navelbine ditartrate
  • NVB
  • vinorelbine tartrate
  • VNB

Primary Outcome Measures :
  1. To determine the maximum tolerated dose of Temsirolimus and Vinorelbine [ Time Frame: 1 month up to 18 months ]
  2. To assess the response rate based on the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 2 months up to 18 months ]

Secondary Outcome Measures :
  1. To evaluate the safety and tolerability of Temsirolimus and Vinorelbine [ Time Frame: 4 weeks up to 36 weeks ]
  2. Progression-free and overall survival [ Time Frame: Up to 18 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Patients with histologically confirmed metastatic or unresectable solid tumors for which standard curative measures do not exist or are no longer effective; histology will be limited to those tumors for which temsirolimus or vinorelbine have reported clinical activity: lung, breast, ovary, cervix, prostate, uterus, renal, bladder and neuroendocrine tumors
  • SWOG performance status of 0-2
  • Projected life expectancy of at least 3 months
  • Provision of informed consent prior to any study-related procedures
  • Negative pregnancy test for women of childbearing potential
  • Female patients must not be pregnant due to the potential mutagenicity and teratogenicity of this treatment; a pregnancy test must be administered 7 days prior to administration of therapy to women of childbearing potential; patients must agree to use some form of contraception while on this study at initiation and for the duration of participation in the study; sexually active males must also use a reliable and appropriate method of contraception; post-menopausal women must be amenorrheic for at least 12 months to be considered of nonchildbearing potential
  • Patients must have recovered from acute toxicities from previous surgery, chemotherapy or radiation therapy
  • ANC >= 1500/mm^3
  • Platelet count >= 100,000 cells/mm^3
  • Hemoglobin >= 9.0g/dL
  • Serum creatinine =< 1.5 mg/dl
  • Hepatic function: Patients must have adequate liver functions: AST or ALT =< 2.5 X upper limit of normal (ULN), alkaline phosphatase =< 2.5 X upper limit of normal; in patients with bone metastasis and no evidence of liver metastasis and bilirubin =< upper limit of normal an alkaline phosphatase =< 5 ULN will be allowed
  • Serum Bilirubin =< 1.0 mg/dL
  • Peripheral neuropathy grade 0-1
  • No other concomitant therapy directed at the cancer is allowed


  • Prior therapy with vinorelbine or an mTor inhibitor
  • Receipt of any investigational agents within 30 days prior to commencing study treatment
  • Last dose of prior chemotherapy discontinued less than 4 weeks before the start of study therapy
  • Last radiation therapy within the last 4 weeks before the start of study therapy, except palliative radiotherapy
  • Any unresolved toxicity greater than CTC grade 1 from previous anticancer therapy, excluding alopecia
  • CTC Grade 1 or greater neuropathy (motor or sensory) at study entry
  • Hematologic function with absolute neutrophils =< 1500/mm^3 and/or platelets < 100,000/mm^3
  • Hepatic function with serum bilirubin greater than the upper institutional limits of normal, ALT and AST > 2.5 times the upper institutional limits of normal
  • Concurrent use of strong inhibitors of CYP3A4: ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine and voriconazole
  • CYP3A4 inducers should be avoided or used with caution; the use of these agents is discouraged: rifabutin, rifampicin, rifapentine, carbamazepine, Phenobarbital, phenytoin and St. John's wart
  • Ongoing long term use of steroids for chronic conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01155258

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United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Wyeth is now a wholly owned subsidiary of Pfizer
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Principal Investigator: Agustin Garcia University of Southern California
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Responsible Party: University of Southern California Identifier: NCT01155258    
Other Study ID Numbers: 0C-09-6
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Carcinoma, Merkel Cell
Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Uterine Cervical Neoplasms
Small Cell Lung Carcinoma
Neoplasms, Germ Cell and Embryonal
Carcinoma, Ovarian Epithelial
Carcinoma, Renal Cell
Endometrial Neoplasms
Carcinoid Tumor
Ovarian Neoplasms
Carcinoma, Neuroendocrine
Breast Neoplasms, Male
Carotid Body Tumor
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Skin Neoplasms
Carcinoma, Medullary
Carcinoma, Islet Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site