Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as gefitinib may interfere with the growth of cancer cells and slow the growth of the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with gefitinib and radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining different regimens of chemotherapy and gefitinib with radiation therapy in treating patients who have stage III non-small cell lung cancer.

Further Study Information

OBJECTIVES:

• Determine the tolerability of paclitaxel and carboplatin followed by radiotherapy with or without paclitaxel and carboplatin followed by gefitinib in patients with stage III non-small cell lung cancer.

• Determine the overall response rate, failure-free survival, and survival in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to CTC performance status (PS) and recent weight loss (PS 2 or PS 0-1 with weight loss of 5% or more within the past 3 months [stratum I] vs PS 0-1 with weight loss less than 5% within the past 3 months [stratum II]).

All patients receive induction therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients then receive therapy based on their assigned stratum.

• Stratum I: Patients receive oral gefitinib once daily for 7 weeks. Patients also undergo concurrent radiotherapy once daily 5 days a week for 7 weeks.

• Stratum II: Patients receive gefitinib and radiotherapy as in stratum I concurrently with paclitaxel IV over 1 hour followed by carboplatin over 30 minutes once weekly for 7 weeks.

Patients are followed every 2 months for 2 years, every 4 months for 2 years, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 18-144 patients (9-72 per stratum) will be accrued for this study within 13 months.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

• Squamous cell carcinoma

• Adenocarcinoma (including bronchoalveolar cell)

• Large cell anaplastic carcinoma (including giant and clear cell carcinoma)

• Unresectable stage IIIA or selected stage IIIB disease

• T1-2, N2 disease allowed

• T3, N2 or T4, N0-2 disease allowed if based on closeness to carina, invasion of mediastinum, or invasion of chest wall

• No T3, N0-1 disease

• No M1 disease

• No direct invasion of vertebral body

• Tumors adjacent to a vertebral body allowed if no bone invasion and if all gross disease can be encompassed in radiation boost field

• Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in radiation boost field

• No scalene, supraclavicular, or contralateral hilar node involvement

• Transudate, cytologically negative, non-bloody pleural effusion allowed if the tumor can be encompassed in radiotherapy field

• Pleural effusions seen on chest CT scan but not on chest x-ray that are too small to tap are allowed

• Pleural effusions appearing only after thoracotomy or other invasive thoracic procedure are allowed

• Measurable disease

• At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

• The following are not considered measurable:

• Pleural effusions

• Completely resected tumors

• Ill-defined masses with post-obstructive changes

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• CTC 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin less than 1.5 mg/dL

• AST less than 2 times upper limit of normal

• No chronic liver disease

Renal:

• Creatinine clearance at least 20 mL/min

Cardiovascular:

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other concurrent uncontrolled illness

• No ongoing or active infection

• No other currently active malignancy (must have completed therapy and be at less than 30% risk of relapse to be eligible) except nonmelanoma skin cancer

• No chronic gastrointestinal disorders (e.g., diarrhea or emetic disorders or malabsorptive conditions) that would preclude study participation

• No psychiatric illness or social situation that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for NSCLC

• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy except steroids for adrenal failure, hormonal therapy for non-disease-related conditions (e.g., insulin for diabetes), or intermittent use of dexamethasone as antiemetic

Radiotherapy:

• See Disease Characteristics

• No prior radiotherapy for NSCLC

• No concurrent palliative radiotherapy

Surgery:

• At least 2 weeks since prior formal exploratory thoracotomy

Other:

• At least 7 days since prior CYP3A4 inducers (e.g., phenytoin, carbamazepine, barbiturates, rifampin, dexamethasone, or Hypericum perforatum [St. John's wort])

• No concurrent CYP3A4 inducers

• No concurrent combination antiretroviral therapy in HIV-positive patients

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

Neal Ready

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00040794
Information obtained from ClinicalTrials.gov on December 14, 2011

Back to Top