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Clinical Trials/NCT00098462
NCT00098462WithdrawnPhase 1

A Phase I/II Trial of ZD1839 (Iressa®) and Rapamycin (Rapamune) in Patients With Advanced Non Small Cell Lung Cancer

Jonsson Comprehensive Cancer Center0 sitesStarted: October 2004Last updated:
Conditions
Drugs

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Withdrawn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

Investigators

Sponsor Class
Other

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