NCT01155258

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 13, 2016

Status Verified

June 1, 2016

Enrollment Period

2.6 years

First QC Date

June 30, 2010

Last Update Submit

June 9, 2016

Conditions

Extensive Stage Small Cell Lung CancerHereditary ParagangliomaMale Breast CancerMalignant ParagangliomaMetastatic Gastrointestinal Carcinoid TumorMetastatic PheochromocytomaPancreatic Polypeptide TumorRecurrent Breast CancerRecurrent Cervical CancerRecurrent Endometrial CarcinomaRecurrent Gastrointestinal Carcinoid TumorRecurrent Islet Cell CarcinomaRecurrent Neuroendocrine Carcinoma of the SkinRecurrent Non-small Cell Lung CancerRecurrent Ovarian Epithelial CancerRecurrent Ovarian Germ Cell TumorRecurrent PheochromocytomaRecurrent Prostate CancerRecurrent Renal Cell CancerRecurrent Small Cell Lung CancerRecurrent Uterine SarcomaRegional Gastrointestinal Carcinoid TumorRegional PheochromocytomaStage III Cervical CancerStage III Endometrial CarcinomaStage III Neuroendocrine Carcinoma of the SkinStage III Ovarian Epithelial CancerStage III Ovarian Germ Cell TumorStage III Prostate CancerStage III Renal Cell CancerStage III Uterine SarcomaStage IIIA Breast CancerStage IIIA Non-small Cell Lung CancerStage IIIB Breast CancerStage IIIB Non-small Cell Lung CancerStage IIIC Breast CancerStage IV Breast CancerStage IV Endometrial CarcinomaStage IV Neuroendocrine Carcinoma of the SkinStage IV Non-small Cell Lung CancerStage IV Ovarian Epithelial CancerStage IV Ovarian Germ Cell TumorStage IV Prostate CancerStage IV Renal Cell CancerStage IV Uterine SarcomaStage IVA Cervical CancerStage IVB Cervical CancerThyroid Gland Medullary Carcinoma

Outcome Measures

Primary Outcomes (2)

  • To determine the maximum tolerated dose of Temsirolimus and Vinorelbine

    1 month up to 18 months

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

    2 months up to 18 months

Secondary Outcomes (2)

  • To evaluate the safety and tolerability of Temsirolimus and Vinorelbine

    4 weeks up to 36 weeks

  • Progression-free and overall survival

    Up to 18 months

Study Arms (1)

Arm I

EXPERIMENTAL

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: temsirolimusDrug: vinorelbine ditartrate

Interventions

temsirolimusDRUG

Given IV

Also known as: CCI-779, cell cycle inhibitor 779, rapamycin analog CCI-779, Torisel
Arm I
vinorelbine ditartrateDRUG

Given IV

Also known as: Biovelbin, Eunades, navelbine ditartrate, NVB, vinorelbine tartrate, VNB
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, MaleParaganglioma, Extra-AdrenalPheochromocytomaBreast NeoplasmsUterine Cervical NeoplasmsEndometrial NeoplasmsCarcinoma, Islet CellCarcinoma, Merkel CellCarcinoma, Non-Small-Cell LungCarcinoma, Ovarian EpithelialProstatic NeoplasmsCarcinoma, Renal CellSmall Cell Lung CarcinomaCarcinoma, Medullary

Interventions

temsirolimusSirolimusVinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesParagangliomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialPancreatic NeoplasmsDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesPolyomavirus InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsCarcinoma, NeuroendocrineCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesOvarian NeoplasmsOvarian DiseasesAdnexal DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesKidney NeoplasmsUrologic NeoplasmsKidney DiseasesUrologic DiseasesNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Agustin Garcia

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 1, 2010

Study Start

June 1, 2010

Primary Completion

January 1, 2013

Study Completion

May 1, 2014

Last Updated

June 13, 2016

Record last verified: 2016-06

Locations

US(1)