CompletedPhase 1NCT01155258

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.

Checked against the public recordLast updated Jun 13, 2016 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations1
SponsorUniversity of Southern California
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
University of Southern California
Interventions being studied
Drug: temsirolimus; Drug: vinorelbine ditartrate
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • USC/Norris Comprehensive Cancer CenterLos Angeles, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 13, 2016. Always confirm current availability with the study team.

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