Extensive Stage Small Cell Lung CancerPhase 1NCT01155258

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

A Phase 1 study testing temsirolimus and vinorelbine ditartrate in people with Extensive Stage Small Cell Lung Cancer and Hereditary Paraganglioma, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Extensive Stage Small Cell Lung Cancer, Hereditary Paraganglioma, Male Breast Cancer
What is being tested?: temsirolimus and vinorelbine ditartrate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: Jun 2010to May 2014
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

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:

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.

Conditions: Extensive Stage Small Cell Lung Cancer, Hereditary Paraganglioma, Male Breast Cancer, Malignant Paraganglioma, Metastatic Gastrointestinal Carcinoid Tumor, Metastatic Pheochromocytoma
Being tested: temsirolimus, vinorelbine ditartrate
Medical subject headings: Breast Neoplasms, Male, Paraganglioma, Extra-Adrenal, Pheochromocytoma, Breast Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Carcinoma, Islet Cell, Carcinoma, Merkel Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

temsirolimusDrug
Also called CCI-779, cell cycle inhibitor 779, rapamycin analog CCI-779, Torisel
Given IV
vinorelbine ditartrateDrug
Also called Biovelbin, Eunades, navelbine ditartrate, NVB
Given IV

Study groups in NCT01155258
Study group	Role	What they receive
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. Receives: Drug: temsirolimus; Drug: vinorelbine ditartrate

What is being measured

The primary outcome is the main question the study is designed to answer.

To determine the maximum tolerated dose of Temsirolimus and Vinorelbine
Measured: 1 month up to 18 months
To assess the response rate based on the Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 2 months up to 18 months

Secondary outcomes (2)

To evaluate the safety and tolerability of Temsirolimus and Vinorelbine
Measured: 4 weeks up to 36 weeks
Progression-free and overall survival
Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010May 2014

First posted1 Jul 2010 (estimated)
Study startJun 2010
Primary completionJan 2013
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01155258
Sponsor's protocol ID: 0C-09-6
Other IDs: NCI-2010-01382
Status last verified: Jun 2016
First submitted: 30 Jun 2010
Last updated: 13 Jun 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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