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

Alternate Title

Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	CALGB-30206 NCT00072527

Objectives

Primary

1. Determine the efficacy of cisplatin and irinotecan followed by carboplatin, etoposide, and radiotherapy, in terms of 2-year survival, in patients with limited stage small cell lung cancer.

Secondary

1. Determine the overall response rate, overall survival, and failure-free survival of patients treated with this regimen.
2. Determine the response rate in patients treated with induction therapy comprising irinotecan and cisplatin.
3. Determine the toxicity and tolerability of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed small cell lung cancer (SCLC)
  • Limited stage disease, defined as the following:
    • Disease restricted to 1 hemithorax with regional lymph node metastases, including hilar, ipsilateral, or contralateral mediastinal lymph nodes
    • No clinically suspected or confirmed supraclavicular lymph node metastases
    • No pathologically enlarged contralateral hilar lymph nodes
    • No pleural effusions that are visible on plain chest radiographs, whether they are cytologically positive or negative
• Unidimensionally measurable disease
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Pleural/pericardial effusions are not considered measurable

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

• No prior chemotherapy for SCLC
• No other concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy except the following:
  • Steroids for adrenal failure
  • Hormones administered for non-disease-related conditions (e.g., insulin for diabetes)
  • Intermittent dexamethasone as an antiemetic or adjunct to prophylactic cranial radiotherapy

Radiotherapy

• See Endocrine therapy
• No prior radiotherapy for SCLC
• No concurrent intensity-modulated radiotherapy

Surgery

• Not specified

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 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

Renal

• Creatinine no greater than 2.0 mg/dL

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No "currently active" second malignancy except nonmelanoma skin cancer
  • Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse

Expected Enrollment

A total of 75 patients will be accrued for this study within 15-24 months.

Outcomes

Efficacy, in terms of survival, at 2 years after initiation of study treatment

Overall response rate as measured by RECIST at completion of study treatment
Overall survival
Failure-free survival
Response rate as measured by RECIST after completion of 2 courses of induction chemotherapy
Toxicity as measured by NCI CTCAE v.30 after completion of 2 courses of chemotherapy
Tolerability as measured by chemotherapy dose-delivered dose delays after completion of study treatment

Outline

This is a multicenter study.

• Induction therapy: Patients receive cisplatin IV over 60 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
• Consolidation therapy: Immediately after the completion of induction therapy, patients receive carboplatin IV over 60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
• Radiotherapy: Beginning on day 1 of consolidation therapy, patients undergo chest radiotherapy daily 5 days a week for 6-7 weeks.

After the completion of consolidation therapy, patients who achieve a complete remission or very good partial remission may undergo prophylactic radiotherapy to the brain.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

Kelley MJ, Bogart JA, Hodgson LD, et al.: CALGB 30206: phase II study of induction cisplatin (P) and irinotecan (I) followed by combination carboplatin (C), etoposide (E), and thoracic radiotherapy for limited stage small cell lung cancer. [Abstract] J Clin Oncol 25 (Suppl 18): A-7565, 400s, 2007.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Michael Kelley, MD, Protocol chair		Ph: 919-286-0411 ext. 7326

Registry Information
Official Title		Induction Cisplatin/Irinotecan Followed By Combination Carboplatin, Etoposide And Chest Radiotherapy In Limited Stage Small Cell Lung Cancer: A Phase II study
Trial Start Date		2003-11-15
Registered in ClinicalTrials.gov		NCT00072527
Date Submitted to PDQ		2003-10-03
Information Last Verified		2005-10-08
NCI Grant/Contract Number		CA31946

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