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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00072527
Recruitment Status : Completed
First Posted : November 5, 2003
Last Update Posted : July 6, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: carboplatin Drug: cisplatin Drug: etoposide Drug: irinotecan hydrochloride Radiation: radiation therapy Phase 2

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction Cisplatin/Irinotecan Followed By Combination Carboplatin, Etoposide And Chest Radiotherapy In Limited Stage Small Cell Lung Cancer: A Phase II Study
Study Start Date : November 2003
Actual Primary Completion Date : June 2007
Actual Study Completion Date : January 2013

Arm Intervention/treatment
Experimental: Induction and consolidation chemotherapy

Induction chemotherapy (Cycles 1 and 2): Patients receive cisplatin 30 mg/m^2 on days 1, 8, 22 and 29 and irinotecan 65 mg/m^2 on days 1, 8, 22 and 29 for cycles 1 and 2.

Consolidation chemotherapy (Cycles 3, 4 and 5 beginning on day 43, week 7): Patients receive carboplatin on days 43, 64 and 85, etoposide 100 mg/m^2 IV on days 43-45, 64-66 and 85-87 and XRT 5 fractions/week starting on day 43

Drug: carboplatin

Drug: cisplatin

Drug: etoposide

Drug: irinotecan hydrochloride

Radiation: radiation therapy

Primary Outcome Measures :
  1. Efficacy, in terms of survival, at 2 years after initiation of study treatment

Secondary Outcome Measures :
  1. Overall response rate as measured by RECIST at completion of study treatment
  2. Overall survival
  3. Failure-free survival
  4. Response rate as measured by RECIST after completion of 2 courses of induction chemotherapy
  5. Toxicity as measured by NCI CTCAE v.30 after completion of 2 courses of chemotherapy
  6. Tolerability as measured by chemotherapy dose-delivered dose delays after completion of study treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  1. Histologically or cytologically documented small cell lung cancer of limited stage.

    1.1 Limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal lymph nodes.

    1.2 Although they are usually defined as having limited stage small cell lung cancer, because of concern about the volume of the radiation field that would be required, patients with clinically suspected or confirmed supraclavicular lymph node metastases, patients with pathologically enlarged contralateral hilar lymph nodes, and patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not, are NOT eligible.

  2. All Patients must have Measurable Disease

    2.1 Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan.

    2.2 Pleural/pericardial effusions are not considered measurable.

  3. Age ≥18
  4. ECOG Performance status 0-2.
  5. Prior Treatment - No prior chemotherapy or radiotherapy for SCLC.
  6. No "currently active" second malignancy other than non-melanoma skin cancers. 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.
  7. Non-pregnant and non-nursing because of significant risk to the fetus/infant.
  8. Required Initial Laboratory Values

    • Granulocytes ≥1,500/µl
    • Platelets ≥100,000/µl
    • Serum Creatinine ≤ULN
    • Bilirubin <1.5 mg/dl
    • SGOT (AST) <2 x ULN

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00072527

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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
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Study Chair: Michael J. Kelley, MD Duke University
Publications of Results:
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.

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Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00072527    
Other Study ID Numbers: CALGB-30206
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000339871 ( Registry Identifier: NCI Physician Data Query )
First Posted: November 5, 2003    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Keywords provided by Alliance for Clinical Trials in Oncology:
limited stage small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors