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NCT Number: NCT01155258

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.

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Key information

Conditions

Extensive Stage Small Cell Lung Cancer Adenocarcinoma Adnexal Diseases Breast Diseases Breast Neoplasms Breast Neoplasms, Male Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Islet Cell Carcinoma, Medullary Carcinoma, Merkel Cell Carcinoma, Neuroendocrine Carcinoma, Non-Small-Cell Lung Carcinoma, Ovarian Epithelial Carcinoma, Renal Cell DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Hereditary Paraganglioma Infections Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Breast Cancer Male Urogenital Diseases Malignant Paraganglioma Metastatic Gastrointestinal Carcinoid Tumor Metastatic Pheochromocytoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Pancreatic Polypeptide Tumor Paraganglioma Paraganglioma, Extra-Adrenal Pheochromocytoma Polyomavirus Infections Prostatic Diseases Prostatic Neoplasms 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 Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Small Cell Lung Carcinoma 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 Thoracic Neoplasms Thyroid Gland Medullary Carcinoma Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

temsirolimus

Drug

Given IV

Other names: CCI-779, cell cycle inhibitor 779, rapamycin analog CCI-779, Torisel

vinorelbine ditartrate

Drug

Given IV

Other names: Biovelbin, Eunades, navelbine ditartrate, NVB, vinorelbine tartrate, VNB

Primary outcomes

  1. To determine the maximum tolerated dose of Temsirolimus and Vinorelbine

    Time frame: 1 month up to 18 months

  2. To assess the response rate based on the Response Evaluation Criteria in Solid Tumors (RECIST)

    Time frame: 2 months up to 18 months

Secondary outcomes

  1. To evaluate the safety and tolerability of Temsirolimus and Vinorelbine

    Time frame: 4 weeks up to 36 weeks

  2. Progression-free and overall survival

    Time frame: Up to 18 months

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

Phase I Clinical Trial of Temsirolimus and Vinorelbine in Advanced Solid Tumors.

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Jul 1, 2010
Registry last updated
Jun 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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