A Phase I/II Trial of ZD1839 (Iressa®) and Rapamycin (Rapamune) in Patients With Advanced Non Small Cell Lung Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Primary Endpoint
- Maximum tolerated dose (Phase I)
Study Overview
Brief Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving gefitinib together with sirolimus may reduce drug resistance and allow the tumor cells to be killed.
PURPOSE: This phase I/II trial is studying the side effects and best dose of sirolimus when given with gefitinib and to see how well they work in treating patients with recurrent or refractory stage IIIB or stage IV non-small cell lung cancer.
Detailed Description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of sirolimus when combined with gefitinib in patients with recurrent or refractory stage IIIB or IV non-small cell lung cancer.
Secondary
- Determine the overall response rate (complete response [CR] and partial response [PR]) in patients treated with this regimen.
- Determine the disease control rate (CR, PR, and stable disease) in patients treated with this regimen.
- Determine the time to progression and overall survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Maximum tolerated dose (Phase I)
Secondary Outcomes
- Overall response (complete response [CR] and partial response [PR]) as measured by RECIST criteria
- Disease control rate (CR, PR, and stable disease) correlated with smoking history
- Time to tumor progression and overall survival
- Quality of life as assessed by the Functional Assessment of Cancer Therapy-Lung (FACT-L)
- Lung cancer subscale from FACT-L