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Gleevec Maintenance Therapy After Induction Irinotecan and Cisplatin in Patients With C-Kit Positive Extensive SCLC

Primary Purpose

Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gleevec
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically or cytologically confirmed extensive-stage SCLC, which is c-kit-positive by immunohistochemistry. Extensive-stage is defined as disease that extends beyond one hemithorax and regional lymph nodes (ipsilateral or contralateral hilar, mediastinal or supraclavicular lymph nodes), or with cytologically positive pleural effusion. No prior chemotherapy for SCLC. Patients who have started therapy with cisplatin and irinotecan, at the dosages mentioned in the protocol, prior to registration can be registered on the trial if done so within 21 days after the start of the first cycle of chemotherapy. Prior palliative radiation therapy will be allowed as long as radiation was completed at least 2 weeks before starting protocol therapy. At least 18 years of age At least one uni-dimensionally measurable lesion or an evaluable outside the field of any prior radiation therapy. 5. Adequate organ function 6. Patients must sign informed consent that details the investigational nature of the study according to the institutional and federal guidelines. Exclusion Criteria: Symptomatic or history of untreated brain or leptomeningeal metastases. Treated patients should be neurologically stable for 2 weeks after completion of appropriate therapy. Previous or concurrent malignancies, with the exception of adequately treated squamous cell or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or any other malignancy treated and in clinical remission for more than 3 years. Major surgery or radiation therapy within 2 weeks of enrollment. Peripheral neuropathy of NCI grade greater than 2. Symptomatic edema from any etiology. Therapeutic anticoagulation with warfarin. Patients can be eligible if they are changed from warfarin to low molecular weight heparin or heparin at least 2 weeks prior to starting Gleevec. Serious concomitant medical illness, including, but not limited to, uncontrolled congestive cardiac failure, uncontrolled angina, myocardial infarction and/or stroke within 3 months, or HIV infection. Acute or chronic liver disease (e.g., chronic active hepatitis, cirrhosis). History of dementia, active psychiatric disorder or any other condition, considered by the treating physician to impair the patient's ability to take oral pills on a daily basis or comply with the protocol requirements. Pregnant or lactating females. All pre-menopausal and peri-menopausal women should have a negative urine pregnancy test prior to enrollment. All patients, men and women, of reproductive potential should agree to use an effective contraceptive method for the duration of the trial and for 3 months after discontinuation of study treatment. Patients should not participate in other investigational agent study while taking part in this trial.

Sites / Locations

  • Univeristy of Michigan Cancer Center

Outcomes

Primary Outcome Measures

Tumor assessment should have been done within 28 days of starting Gleevec. Tumor assessment will be done every 8 weeks while on Gleevec.

Secondary Outcome Measures

Clinical assessment, labs, and toxicity will be done weekly from weeks 2 through 8. Evaluation may be done more frequently after the first 8 weeks if required, but should be done at least every 4 weeks.

Full Information

First Posted
September 7, 2005
Last Updated
November 12, 2010
Sponsor
University of Michigan Rogel Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00156286
Brief Title
Gleevec Maintenance Therapy After Induction Irinotecan and Cisplatin in Patients With C-Kit Positive Extensive SCLC
Official Title
Phase II Trial of Gleevec (Imatinib Mesylate, STI571) Maintenance Therapy After Induction Irinotecan and Cisplatin in Patients With C-Kit Positive, Extensive-Stage Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Michigan Rogel Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study involves being treated initially with a combination of drugs called irinotecan and cisplatin (induction therapy), followed by treatment with a drug called Gleevec (maintenance therapy). The main purpose of this study is to determine if this type of treatment will delay the growth of the tumor and if so, for how long. The investigators also want to find out how the tumor is affected solely by induction therapy with irinotecan and cisplatin, what side-effects occur when Gleevec maintenance therapy is used, and if this treatment (induction followed by maintenance therapy) will improve the duration of survival

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gleevec
Primary Outcome Measure Information:
Title
Tumor assessment should have been done within 28 days of starting Gleevec. Tumor assessment will be done every 8 weeks while on Gleevec.
Secondary Outcome Measure Information:
Title
Clinical assessment, labs, and toxicity will be done weekly from weeks 2 through 8. Evaluation may be done more frequently after the first 8 weeks if required, but should be done at least every 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed extensive-stage SCLC, which is c-kit-positive by immunohistochemistry. Extensive-stage is defined as disease that extends beyond one hemithorax and regional lymph nodes (ipsilateral or contralateral hilar, mediastinal or supraclavicular lymph nodes), or with cytologically positive pleural effusion. No prior chemotherapy for SCLC. Patients who have started therapy with cisplatin and irinotecan, at the dosages mentioned in the protocol, prior to registration can be registered on the trial if done so within 21 days after the start of the first cycle of chemotherapy. Prior palliative radiation therapy will be allowed as long as radiation was completed at least 2 weeks before starting protocol therapy. At least 18 years of age At least one uni-dimensionally measurable lesion or an evaluable outside the field of any prior radiation therapy. 5. Adequate organ function 6. Patients must sign informed consent that details the investigational nature of the study according to the institutional and federal guidelines. Exclusion Criteria: Symptomatic or history of untreated brain or leptomeningeal metastases. Treated patients should be neurologically stable for 2 weeks after completion of appropriate therapy. Previous or concurrent malignancies, with the exception of adequately treated squamous cell or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or any other malignancy treated and in clinical remission for more than 3 years. Major surgery or radiation therapy within 2 weeks of enrollment. Peripheral neuropathy of NCI grade greater than 2. Symptomatic edema from any etiology. Therapeutic anticoagulation with warfarin. Patients can be eligible if they are changed from warfarin to low molecular weight heparin or heparin at least 2 weeks prior to starting Gleevec. Serious concomitant medical illness, including, but not limited to, uncontrolled congestive cardiac failure, uncontrolled angina, myocardial infarction and/or stroke within 3 months, or HIV infection. Acute or chronic liver disease (e.g., chronic active hepatitis, cirrhosis). History of dementia, active psychiatric disorder or any other condition, considered by the treating physician to impair the patient's ability to take oral pills on a daily basis or comply with the protocol requirements. Pregnant or lactating females. All pre-menopausal and peri-menopausal women should have a negative urine pregnancy test prior to enrollment. All patients, men and women, of reproductive potential should agree to use an effective contraceptive method for the duration of the trial and for 3 months after discontinuation of study treatment. Patients should not participate in other investigational agent study while taking part in this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Kalemkerian, M.D.
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gleevec Maintenance Therapy After Induction Irinotecan and Cisplatin in Patients With C-Kit Positive Extensive SCLC

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