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, such as cisplatin, irinotecan, carboplatin, and etoposide, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin and irinotecan followed by carboplatin, etoposide, and radiation therapy in treating patients who have limited-stage small cell lung cancer.

Further Study Information

OBJECTIVES:

Primary

• 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

• Determine the overall response rate, overall survival, and failure-free survival of patients treated with this regimen.

• Determine the response rate in patients treated with induction therapy comprising irinotecan and cisplatin.

• Determine the toxicity and tolerability of this regimen in these patients.

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.

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

Eligibility 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

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 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

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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

Michael J. Kelley

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00072527
Information obtained from ClinicalTrials.gov on December 14, 2011

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