Gefitinib and Sirolimus in Treating Patients With Recurrent or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT00098462 | Withdrawn Phase 1

• 3 other identifiers: CDR0000401501UCLA-0407057-01ZENECA-IRUSIRES0281
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (Phase I)

Secondary Outcomes (5)

• 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

Interventions

gefitinib DRUG

sirolimus DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer * Stage IIIB or IV disease * Recurrent or refractory disease * Received ≥ 1 prior platinum-containing chemotherapy regimen * Unidimensionally measurable disease that has not been irradiated * No newly diagnosed untreated brain metastases or spinal cord compression * Paraffin-embedded tumor tissue or slides available PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Adequate bone marrow function * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Adequate hepatic function * No severe or uncontrolled hepatic disease Renal * Adequate renal function * Creatinine ≤ 3.0 times upper limit of normal * No severe or uncontrolled renal disease Cardiovascular * Adequate cardiac function * No severe or uncontrolled cardiac disease * No uncontrolled hyperlipidemia Pulmonary * No unstable or uncompensated respiratory disease * No clinically active interstitial lung disease * Patients with chronic stable radiographic changes who are asymptomatic are eligible Gastrointestinal * Able to take oral medication * No gastrointestinal condition (e.g., peptic ulcer disease) that would affect absorption Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No serious infection * No known severe hypersensitivity to gefitinib or any of its excipients * No other malignancy within the past 5 years except treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No other severe or uncontrolled systemic disease * No significant clinical disorder or laboratory finding that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * More than 14 days since prior biologic therapy * No prior cetuximab, panitumumab, or bevacizumab Chemotherapy * See Disease Characteristics * More than 4 weeks since prior cytotoxic chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * More than 3 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * Recovered from prior oncologic or other major surgery * No prior gastrointestinal surgery affecting absorption * No concurrent surgery, including ophthalmic surgery, during and for 1 week after study treatment Other * Recovered from all prior therapy * More than 30 days since prior investigational agents * No other prior HER1/epidermal growth factor receptor axis agents, including the following: * Gefitinib * Erlotinib * CI-1033 * Lapatinib * No other prior vascular endothelial growth factor axis agents, including the following: * ZD6474 * Vatalanib * No concurrent CYP3A4 inducers, including the following: * Phenytoin * Carbamazepine * Rifampin * Phenobarbital * Barbiturates * Hypericum perforatum (St. John's wort) * No other concurrent systemic treatment for the malignancy * No concurrent bisphosphonates for symptomatic bone metastases * No concurrent systemic retinoids

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib; Sirolimus

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrolides; Lactones; Organic Chemicals

Study Officials

• Fairooz F. Kabbinavar, MD

  Jonsson Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2004
• First Posted: December 8, 2004
• Study Start: October 1, 2004
• Last Updated: October 4, 2012

Record last verified: 2012-10