Temsirolimus And Vinorelbine Ditartrate In Treating Patients With Unresectable Or Metastatic Solid Tumors

Study Overview

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

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.

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.

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

0C-09-6
NCI-2010-01382

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-06-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-06-09
First Submitted that Met QC Criteria 2010-06-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-06-13
First Posted (ESTIMATED) 2010-07-01	Results First Posted N/A	Last Verified 2016-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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 DRUG: vinorelbine ditartrate Given IV

Participant Group/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

DRUG: vinorelbine ditartrate

Given IV

Primary Outcome Measures	Measure Description	Time Frame
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	Measure Description	Time Frame
To evaluate the safety and tolerability of Temsirolimus and Vinorelbine		4 weeks up to 36 weeks
Progression-free and overall survival		Up to 18 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

PRINCIPAL_INVESTIGATOR: Agustin Garcia, University of Southern California

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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