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

June 9, 2016 updated by: University of Southern California

Phase I Clinical Trial of Temsirolimus and Vinorelbine in Advanced 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion

  • 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

Exclusion

  • 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

Study Plan

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

How is the study designed?

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
Other Names:
  • Torisel
  • CCI-779
  • cell cycle inhibitor 779
  • rapamycin analog CCI-779
Drug: vinorelbine ditartrate
Given IV
Other Names:
  • Eunades
  • navelbine ditartrate
  • NVB
  • VNB
  • Biovelbin
  • vinorelbine tartrate

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

University of Southern California

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

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 Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

June 30, 2010

First Submitted That Met QC Criteria

June 30, 2010

First Posted (ESTIMATE)

July 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 13, 2016

Last Update Submitted That Met QC Criteria

June 9, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0C-09-6
  • NCI-2010-01382

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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