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

This study is ongoing, but not recruiting participants.
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: February 5, 2014
Last verified: February 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
  • To assess the response rate based on the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 2 months up to 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety and tolerability of Temsirolimus and Vinorelbine [ Time Frame: 4 weeks up to 36 weeks ] [ Designated as safety issue: Yes ]
  • Progression-free and overall survival [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: June 2010
Estimated Study Completion Date: December 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
Genders Eligible for Study:   Both
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

No publications provided

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: February 5, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 23, 2014