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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00072527
• Other study ID #: CALGB-30206
• Secondary ID: U10CA031946CDR00
• Status: Completed
• Phase: Phase 2
• First received: November 4, 2003
• Last updated: July 1, 2016
• Start date: November 2003
• Est. completion date: January 2013

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 2013
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• carboplatin
IV
• cisplatin
IV
• etoposide
IV
• irinotecan hydrochloride
IV

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	St. Joseph Medical Center	Bloomington	Illinois
United States	Veterans Affairs Medical Center - Buffalo	Buffalo	New York
United States	Cancer Institute of New Jersey at the Cooper University Hospital	Camden	New Jersey
United States	Graham Hospital	Canton	Illinois
United States	Memorial Hospital	Carthage	Illinois
United States	Saint Luke's Hospital	Chesterfield	Missouri
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University	Columbus	Ohio
United States	Danville Regional Medical Center	Danville	Virginia
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Union Hospital Cancer Center at Union Hospital	Elkton MD	Maryland
United States	Eureka Hospital	Eureka	Illinois
United States	Hudner Oncology Center at Saint Anne's Hospital	Fall River	Massachusetts
United States	Fort Wayne Medical Oncology and Hematology, Incorporated	Fort Wayne	Indiana
United States	Galesburg Clinic	Galesburg	Illinois
United States	Galesburg Cottage Hospital	Galesburg	Illinois
United States	InterCommunity Cancer Center of Western Illinois	Galesburg	Illinois
United States	Comprehensive Cancer Center at Gaston Memorial	Gastonia	North Carolina
United States	Charles R. Wood Cancer Center at Glens Falls Hospital	Glens Falls	New York
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Bon Secours St. Francis Health System	Greenville	South Carolina
United States	CCOP - Greenville	Greenville	South Carolina
United States	Greenville Hospital System Cancer Center	Greenville	South Carolina
United States	Mason District Hospital	Havana	Illinois
United States	Pardee Memorial Hospital	Hendersonville	North Carolina
United States	Hopedale Medical Complex	Hopedale	Illinois
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Kingsbury Center for Cancer Care at Cheshire Medical Center	Keene	New Hampshire
United States	Kewanee Hospital	Kewanee	Illinois
United States	Lenoir Memorial Cancer Center	Kinston	North Carolina
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Beebe Medical Center	Lewes	Delaware
United States	McDonough District Hospital	Macomb	Illinois
United States	North Shore University Hospital	Manhasset	New York
United States	Fairview University Medical Center - University Campus	Minneapolis	Minnesota
United States	Mercy Memorial Hospital System	Monroe	Michigan
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	BroMenn Regional Medical Center	Normal	Illinois
United States	Community Cancer Center	Normal	Illinois
United States	Methodist Cancer Center at Methodist Hospital - Omaha	Omaha	Nebraska
United States	Community Hospital of Ottawa	Ottawa	Illinois
United States	Oncology Hematology Associates of Central Illinois - Ottawa	Ottawa	Illinois
United States	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Proctor Hospital	Peoria	Illinois
United States	Illinois Valley Community Hospital	Peru	Illinois
United States	Comprehensive Cancer Center at Moore Regional Hospital	Pinehurst	North Carolina
United States	Saint Joseph Regional Medical Center - Plymouth Campus	Plymouth	Indiana
United States	Perry Memorial Hospital	Princeton	Illinois
United States	Miriam Hospital at Lifespan	Providence	Rhode Island
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Frisbie Memorial Hospital	Rochester	New Hampshire
United States	Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	St. Margaret's Hospital	Spring Valley	Illinois
United States	Valley Cancer Center	Spring Valley	Illinois
United States	Siteman Cancer Center at Barnes-Jewish Hospital	St Louis	Missouri
United States	Missouri Baptist Cancer Center	St. Louis	Missouri
United States	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York
United States	Community General Hospital of Greater Syracuse	Syracuse	New York
United States	SUNY Upstate Medical University Hospital	Syracuse	New York
United States	Faxton Regional Cancer Center	Utica	New York
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	St. Francis Hospital	Wilmington	Delaware
United States	Zimmer Cancer Center at New Hanover Regional Medical Center	Wilmington	North Carolina
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	Forsyth Regional Cancer Center at Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Cl

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy, in terms of survival, at 2 years after initiation of study treatment			No
Secondary	Overall response rate as measured by RECIST at completion of study treatment			No
Secondary	Overall survival			No
Secondary	Failure-free survival			No
Secondary	Response rate as measured by RECIST after completion of 2 courses of induction chemotherapy			No
Secondary	Toxicity as measured by NCI CTCAE v.30 after completion of 2 courses of chemotherapy			Yes
Secondary	Tolerability as measured by chemotherapy dose-delivered dose delays after completion of study treatment			Yes