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Trial record 1 of 1 for:    NCT01155258
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Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT01155258
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : June 13, 2016
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
University of Southern California

Tracking Information
First Submitted Date  ICMJE June 30, 2010
First Posted Date  ICMJE July 1, 2010
Last Update Posted Date June 13, 2016
Study Start Date  ICMJE June 2010
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2010)
  • To determine the maximum tolerated dose of Temsirolimus and Vinorelbine [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2010)
Maximum tolerated dose and dose limiting toxicity [ Time Frame: First cycle of study therapy ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2010)
  • To evaluate the safety and tolerability of Temsirolimus and Vinorelbine [ Time Frame: 4 weeks up to 36 weeks ]
  • Progression-free and overall survival [ Time Frame: Up to 18 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2010)
  • Response rate as assessed by RECIST [ Time Frame: Until patient goes off study ]
  • Toxicity and adverse events as assessed by CTCAE version 3.0 [ Time Frame: Until patient goes off study ]
  • Progression-free and overall survival [ Time Frame: First day of treatment to the first observation of disease progression. For overall survival - from first treatment to time of death. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors
Official Title  ICMJE Phase I Clinical Trial of Temsirolimus and Vinorelbine in Advanced Solid Tumors.
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: temsirolimus
  • Drug: vinorelbine ditartrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2012)
19
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2010)
20
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01155258
Other Study ID Numbers  ICMJE 0C-09-6
NCI-2010-01382
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Agustin Garcia University of Southern California
PRS Account University of Southern California
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP