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

Alternate Title

Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI	RTOG-0241 NCT00059761

Objectives

1. Determine the maximum tolerated dose of irinotecan administered with cisplatin and thoracic radiotherapy (given at two different schedules) in patients with limited stage small cell lung cancer.
2. Determine the qualitative and quantitative toxicity and non-dose-limiting toxicity of these regimens in these patients.
3. Determine the reversibility of all toxic effects associated with these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed small cell lung cancer by one of two methods:
  • Fine needle aspiration biopsy
  • Two positive sputa



• Must have limited disease as defined by all of the following:
  • Stage I-IIIB
  • Confined to 1 hemithorax
  • No T4 tumor based on malignant pleural or pericardial effusion
    • Patients with pleural effusion too small to tap under CT guidance and not evident on chest x-ray are allowed
  • No N3 disease based on contralateral hilar or contralateral supraclavicular involvement



• Measurable or evaluable disease
  • Tumor must be able to be encompassed by specified radiotherapy fields without unacceptable risk of serious pulmonary compromise



• No complete tumor resection



• No pericardial effusion (regardless of cytology)

Prior/Concurrent Therapy:

Biologic therapy

• No prior biologic therapy

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy
• No concurrent intensity-modulated radiotherapy

Surgery

• See Disease Characteristics

Other

• At least 7 days since prior enzyme-inducing anti-convulsant drugs (EIACDs) (e.g., phenytoin, carbamazepine, or phenobarbital) if used on a regular basis for more than 2 weeks
  • Less than 2 weeks of regular use of EIACDs does not require a 7-day wash-out period
• At least 14 days since prior Hypericum perforatum (St. John's wort)
• No concurrent EIACDs
• No concurrent amifostine during chemoradiotherapy
• Concurrent gabapentin or other non-EIACDs allowed

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count at least 1,500/mm³
• Platelet count at least 120,000/mm³

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• No known Gilbert's disease

Renal

• Creatinine no greater than 1.5 mg/dL

Cardiovascular

• No myocardial infarction within the past 6 months
• No symptomatic heart disease

Pulmonary

• FEV₁ at least 1.0 L/sec
• No uncontrolled bronchospasms
• No uncompensated chronic obstructive pulmonary disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No pre-existing peripheral neuropathy grade 2 or greater
• No other malignancy within the past 2 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the bladder or cervix
• No other concurrent serious medical illness

Expected Enrollment

A total of 12-36 patients (6-18 per group) will be accrued for this study within 18 months.

Outcomes

Maximum tolerated dose of irinotecan in combination with cisplatin and thoracic radiotherapy (45 Gy BID or 70 Gy daily) by toxicity assessment (Common Toxicity Criteria version 3.0) during acute and late toxicity

Response rate, time to progression, and survival at median and 2 years

Outline

This is a non-randomized, dose-escalation study of irinotecan. Patients are assigned to 1 of 2 radiotherapy (RT) treatment groups.

• Radiotherapy:
  • Group I: Patients undergo thoracic RT twice daily, 5 days a week, for 3 weeks.
  
  
  
  • Group II: Patients undergo thoracic RT once daily, 5 days a week, for 7 weeks.
  
  
  



• Concurrent chemotherapy: Patients receive irinotecan IV over 60-90 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 1 course for group I and 2 courses for group II.



• Post RT chemotherapy: Patients receive irinotecan and cisplatin as above for 3 courses for group I and 2 courses, beginning after RT is complete, for group II.

Sequential cohorts of 6 patients per group receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 1 year and then 6 months for 4 years.

Langer CJ, Swann S, Werner-Wasik M, et al.: Phase I study of irinotecan (Ir) and cisplatin (DDP) in combination with thoracic radiotherapy (RT), either twice daily (45 Gy) or once daily (70 Gy), in patients with limited (Ltd) small cell lung carcinoma (SCLC): early analysis of RTOG 0241. [Abstract] J Clin Oncol 24 (Suppl 18): A-7058, 378s, 2006.

Langer C, Swann S, Werner-Wasik M, et al.: Phase I study of combination irinotecan and cisplatin and either twice daily thoracic radiation (45Gy) or once daily thoracic radiotherapy (70Gy) in patients with limited small cell lung carcinoma (SCLC): early toxicity analysis of RTOG 0241. [Abstract] Lung Cancer 49 (Suppl 2): A-P-777, S323, 2005.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Corey Langer, MD, Protocol chair		Ph: 215-728-2985; 888-369-2427 Email: cj_langer@fccc.edu
Maria Werner-Wasik, MD, Protocol co-chair		Ph: 215-955-7679; 800-533-3669 Email: maria.werner-wasik@mail.tju.edu

Registry Information
Official Title		Phase I Study of Irinotecan and Cisplatin in Combination with Twice Daily Thoracic Radiotherapy (45 Gy) or Once Daily Thoracic Radiotherapy (70 Gy) for Patients with Limited Stage Small Cell Lung Cancer
Trial Start Date		2003-03-17
Registered in ClinicalTrials.gov		NCT00059761
Date Submitted to PDQ		2002-11-21
Information Last Verified		2005-11-30
NCI Grant/Contract Number		CA21661

Back to Top