NCT01155258|CompletedPhase 1

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

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

University of Southern California ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

0C-09-6

Secondary identifiers

NCI-2010-01382

Study Type

interventional

Actual enrollment (reported)

Locations

1 country

Sites

Timeline

Study Start

June 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2013

Actual (reported)

Study Completion

May 2014

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 19 participants
Study completion date: May 2014
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2010
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
June 30, 2010
Actual (reported)
First Posted
July 1, 2010
Actual (reported)
Primary Completion
January 2013
Actual (reported)
Study Completion
May 2014
Actual (reported)

Last Updated: June 13, 2016
Status Verified: June 2016
Last Update Submitted: June 9, 2016

Conditions

Extensive Stage Small Cell Lung Cancer Hereditary Paraganglioma Male Breast Cancer Malignant Paraganglioma Metastatic Gastrointestinal Carcinoid Tumor

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

Contact the study team to confirm eligibility.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (1)

Arm I

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (1)

Arm I

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations