This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01155258
First received: June 30, 2010
Last updated: June 9, 2016
Last verified: June 2016
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 19
Study Start Date: June 2010
Study Completion Date: May 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155258

Locations
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
Investigators
Principal Investigator: Agustin Garcia University of Southern California
  More Information

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01155258     History of Changes
Other Study ID Numbers: 0C-09-6
NCI-2010-01382
Study First Received: June 30, 2010
Last Updated: June 9, 2016

Additional relevant MeSH terms:
Carcinoma
Breast Neoplasms
Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Sarcoma
Uterine Cervical Neoplasms
Small Cell Lung Carcinoma
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Carcinoma, Renal Cell
Endometrial Neoplasms
Germinoma
Carcinoid Tumor
Neuroendocrine Tumors
Breast Neoplasms, Male
Pheochromocytoma
Carcinoma, Neuroendocrine
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Skin Neoplasms
Paraganglioma
Carotid Body Tumor
Carcinoma, Medullary
Thyroid Neoplasms
Carcinoma, Islet Cell
Carcinoma, Merkel Cell
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 21, 2017