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

Induction Cisplatin/Irinotecan Followed By Combination Carboplatin, Etoposide And Chest Radiotherapy In Limited Stage Small Cell Lung Cancer: A Phase II Study

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Radiation: radiation therapy; Drug: carboplatin; Drug: cisplatin; Drug: etoposide; Drug: irinotecan hydrochloride

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Lewes, Delaware, United States, 19958
      • Beebe Medical Center
    • Newark, Delaware, United States, 19718
      • CCOP - Christiana Care Health Services
    • Wilmington, Delaware, United States, 19805
      • St. Francis Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20307
      • Walter Reed Army Medical Center
  • Georgia
    • Savannah, Georgia, United States, 31403
      • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • St. Joseph Medical Center
    • Canton, Illinois, United States, 61520
      • Graham Hospital
    • Carthage, Illinois, United States, 62321
      • Memorial Hospital
    • Chicago, Illinois, United States, 60637-1470
      • University of Chicago Cancer Research Center
    • Eureka, Illinois, United States, 61530
      • Eureka Hospital
    • Galesburg, Illinois, United States, 61401
      • Galesburg Cottage Hospital
    • Galesburg, Illinois, United States, 61401
      • Galesburg Clinic
    • Galesburg, Illinois, United States, 61401
      • InterCommunity Cancer Center of Western Illinois
    • Havana, Illinois, United States, 62644
      • Mason District Hospital
    • Hopedale, Illinois, United States, 61747
      • Hopedale Medical Complex
    • Kewanee, Illinois, United States, 61443
      • Kewanee Hospital
    • Macomb, Illinois, United States, 61455
      • Mcdonough District Hospital
    • Normal, Illinois, United States, 61761
      • Bromenn Regional Medical Center
    • Normal, Illinois, United States, 61761
      • Community Cancer Center
    • Ottawa, Illinois, United States, 61350
      • Community Hospital of Ottawa
    • Ottawa, Illinois, United States, 61350
      • Oncology Hematology Associates of Central Illinois - Ottawa
    • Pekin, Illinois, United States, 61554
      • Cancer Treatment Center at Pekin Hospital
    • Peoria, Illinois, United States, 61614
      • Proctor Hospital
    • Peoria, Illinois, United States, 61603
      • Methodist Medical Center of Illinois
    • Peoria, Illinois, United States, 61637
      • OSF St. Francis Medical Center
    • Peoria, Illinois, United States, 61615
      • CCOP - Illinois Oncology Research Association
    • Peoria, Illinois, United States, 61615
      • Oncology/Hematology Associates of Central Illinois, P.C.
    • Peru, Illinois, United States, 61354
      • Illinois Valley Community Hospital
    • Princeton, Illinois, United States, 61356
      • Perry Memorial Hospital
    • Spring Valley, Illinois, United States, 61362
      • St. Margaret's Hospital
    • Spring Valley, Illinois, United States, 61362
      • Valley Cancer Center
  • Indiana
    • Elkhart, Indiana, United States, 46515
      • Elkhart General Hospital
    • Fort Wayne, Indiana, United States, 46815
      • Fort Wayne Medical Oncology and Hematology, Incorporated
    • La Porte, Indiana, United States, 46350
      • Center for Cancer Therapy at LaPorte Hospital and Health Services
    • Plymouth, Indiana, United States, 46544
      • Saint Joseph Regional Medical Center - Plymouth Campus
    • South Bend, Indiana, United States, 46601
      • Memorial Hospital of South Bend
    • South Bend, Indiana, United States, 46601
      • CCOP - Northern Indiana CR Consortium
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Holden Comprehensive Cancer Center at University of Iowa
  • Maryland
    • Elkton MD, Maryland, United States, 21921
      • Union Hospital Cancer Center at Union Hospital
  • Massachusetts
    • Fall River, Massachusetts, United States, 02721
      • Hudner Oncology Center at Saint Anne's Hospital
  • Michigan
    • Monroe, Michigan, United States, 48162
      • Mercy Memorial Hospital System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Fairview University Medical Center - University Campus
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Saint Luke's Hospital
    • Columbia, Missouri, United States, 65203
      • Ellis Fischel Cancer Center at University of Missouri - Columbia
    • Kansas City, Missouri, United States, 64131
      • CCOP - Kansas City
    • St Louis, Missouri, United States, 63110
      • Siteman Cancer Center at Barnes-Jewish Hospital
    • St. Louis, Missouri, United States, 63131
      • Missouri Baptist Cancer Center
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Methodist Cancer Center at Methodist Hospital - Omaha
  • New Hampshire
    • Keene, New Hampshire, United States, 03431
      • Kingsbury Center for Cancer Care at Cheshire Medical Center
    • Lebanon, New Hampshire, United States, 03756
      • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • Rochester, New Hampshire, United States, 03867
      • Frisbie Memorial Hospital
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cancer Institute of New Jersey at the Cooper University Hospital
  • New York
    • Buffalo, New York, United States, 14215
      • Veterans Affairs Medical Center - Buffalo
    • Glens Falls, New York, United States, 12801
      • Charles R. Wood Cancer Center at Glens Falls Hospital
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New Hyde Park, New York, United States, 11042
      • Long Island Jewish Medical Center
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University Hospital
    • Syracuse, New York, United States, 13057
      • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
    • Syracuse, New York, United States, 13215
      • Community General Hospital of Greater Syracuse
    • Utica, New York, United States, 13502
      • Faxton Regional Cancer Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Comprehensive Cancer Center
    • Gastonia, North Carolina, United States, 28053
      • Comprehensive Cancer Center at Gaston Memorial
    • Goldsboro, North Carolina, United States, 27534
      • Wayne Memorial Hospital, Incorporated
    • Hendersonville, North Carolina, United States, 28791
      • Pardee Memorial Hospital
    • Kinston, North Carolina, United States, 28501
      • Lenoir Memorial Cancer Center
    • Pinehurst, North Carolina, United States, 28374
      • Comprehensive Cancer Center at Moore Regional Hospital
    • Wilmington, North Carolina, United States, 28401
      • Zimmer Cancer Center at New Hanover Regional Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center at Wake Forest University
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Regional Cancer Center at Forsyth Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
    • Providence, Rhode Island, United States, 02906
      • Miriam Hospital at Lifespan
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • CCOP - Greenville
    • Greenville, South Carolina, United States, 29601
      • Bon Secours St. Francis Health System
    • Greenville, South Carolina, United States, 29605
      • Greenville Hospital System Cancer Center
  • Virginia
    • Danville, Virginia, United States, 24541
      • Danville Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

Radiation: radiation therapy; Drug: carboplatin; IV; Drug: cisplatin; IV; Drug: etoposide; IV; Drug: irinotecan hydrochloride; IV

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Overall survival
Overall response rate as measured by RECIST at completion of study treatment
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

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Michael J. Kelley, MD, Duke University

Publications and helpful links

General Publications

• Kelley MJ, Bogart JA, Hodgson LD, Ansari RH, Atkins JN, Pang H, Green MR, Vokes EE. Phase II study of induction cisplatin and irinotecan followed by concurrent carboplatin, etoposide, and thoracic radiotherapy for limited-stage small-cell lung cancer, CALGB 30206. J Thorac Oncol. 2013 Jan;8(1):102-8. doi: 10.1097/JTO.0b013e31827628e1.

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: November 4, 2003
• First Submitted That Met QC Criteria: November 4, 2003
• First Posted (Estimate): November 5, 2003

Study Record Updates

• Last Update Posted (Estimate): July 6, 2016
• Last Update Submitted That Met QC Criteria: July 1, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: limited stage small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Carboplatin; Etoposide; Irinotecan
• Other Study ID Numbers: CALGB-30206; U10CA031946 (U.S. NIH Grant/Contract); CDR0000339871 (Registry Identifier: NCI Physician Data Query)