Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy, Radiation Therapy, and Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	CALGB-30106 NCT00040794

Objectives

1. 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.
2. Determine the overall response rate, failure-free survival, and survival in patients treated with these regimens.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• CTC 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

Outcomes

Tolerability
Overall response rate
Failure-free survival
Survival

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.

Ready N, Janne P, Herndon J, et al.: Chemoradiotherapy (CRT) and gefitinib (G) in stage III non-small cell lung cancer (NSCLC): a CALGB stratified phase II trial. [Abstract] J Clin Oncol 24 (Suppl 18): 7046, 375s, 2006.

Ready N, Herndon J, Vokes E, et al.: Initial cohort toxicity evaluation for chemoradiotherapy (CRT) and ZD1839 in stage III non-small cell lung cancer (NSCLC): a CALGB stratified phase II trial. [Abstract] J Clin Oncol 22 (Suppl 14): A-7078, 635s, 2004.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Neal Ready, MD, PhD, Protocol chair		Ph: 919-681-6932 Email: ready007@mc.duke.edu

Registry Information
Official Title		Induction Paclitaxel And Carboplatin Followed By Either Radiation Or Concomitant Radiation With Weekly Paclitaxel And Carboplatin In Stage III Non-Small Cell Lung Cancer. A Phase II Study
Trial Start Date		2002-05-15
Registered in ClinicalTrials.gov		NCT00040794 1
Date Submitted to PDQ		2002-05-02
Information Last Verified		2008-04-16
NCI Grant/Contract Number		CA31946

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00040794