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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: November 4, 2003
Last updated: June 24, 2015
Last verified: June 2015

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 Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: cisplatin
Drug: etoposide
Drug: irinotecan hydrochloride
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Efficacy, in terms of survival, at 2 years after initiation of study treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate as measured by RECIST at completion of study treatment [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Failure-free survival [ Designated as safety issue: No ]
  • Response rate as measured by RECIST after completion of 2 courses of induction chemotherapy [ Designated as safety issue: No ]
  • Toxicity as measured by NCI CTCAE v.30 after completion of 2 courses of chemotherapy [ Designated as safety issue: Yes ]
  • Tolerability as measured by chemotherapy dose-delivered dose delays after completion of study treatment [ Designated as safety issue: Yes ]

Enrollment: 78
Study Start Date: November 2003
Study Completion Date: January 2013
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00072527

  Show 76 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Michael J. Kelley, MD Duke University
  More Information

Additional Information:
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.

Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00072527     History of Changes
Other Study ID Numbers: CALGB-30206, U10CA031946, CDR0000339871
Study First Received: November 4, 2003
Last Updated: June 24, 2015
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
limited stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on November 30, 2015