Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Phase I Study of Irinotecan and Cisplatin in Combination With Twice Daily Thoracic Radiotherapy (45 Gy) or Once Daily Thoracic Radiotherapy (70 Gy) for Patients With Limited Stage Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00059761
• Other study ID #: RTOG-0241
• Secondary ID: CDR0000269348
• Status: Completed
• Phase: Phase 1
• First received: May 6, 2003
• Last updated: November 14, 2015
• Start date: March 2003
• Est. completion date: November 2013

Study information

• Verified date: November 2015
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy 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 I trial to study the effect on the body when combining irinotecan and cisplatin with radiation therapy in treating patients who have limited-stage small cell lung cancer that could not be completely removed during surgery.

Description:

OBJECTIVES:

• Determine the maximum tolerated dose of irinotecan administered with cisplatin and thoracic radiotherapy (given at two different schedules) in patients with limited stage small cell lung cancer.

• Determine the qualitative and quantitative toxicity and non-dose-limiting toxicity of these regimens in these patients.

• Determine the reversibility of all toxic effects associated with these regimens in these patients.

OUTLINE: This is a non-randomized, dose-escalation study of irinotecan. Patients are assigned to 1 of 2 radiotherapy (RT) treatment groups.

• Radiotherapy:

• Group I: Patients undergo thoracic RT twice daily, 5 days a week, for 3 weeks.

• Group II: Patients undergo thoracic RT once daily, 5 days a week, for 7 weeks.

• Concurrent chemotherapy: Patients receive irinotecan IV over 60-90 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 1 course for group I and 2 courses for group II.

• Post RT chemotherapy: Patients receive irinotecan and cisplatin as above for 3 courses for group I and 2 courses, beginning after RT is complete, for group II.

Sequential cohorts of 6 patients per group receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 1 year and then 6 months for 4 years.

PROJECTED ACCRUAL: A total of 12-36 patients (6-18 per group) will be accrued for this study within 18 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2013
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed small cell lung cancer by one of two methods:

• Fine needle aspiration biopsy

• Two positive sputa

• Must have limited disease as defined by all of the following:

• Stage I-IIIB

• Confined to 1 hemithorax

• No T4 tumor based on malignant pleural or pericardial effusion

• Patients with pleural effusion too small to tap under CT guidance and not evident on chest x-ray are allowed

• No N3 disease based on contralateral hilar or contralateral supraclavicular involvement

• Measurable or evaluable disease

• Tumor must be able to be encompassed by specified radiotherapy fields without unacceptable risk of serious pulmonary compromise

• No complete tumor resection

• No pericardial effusion (regardless of cytology)

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count at least 1,500/mm^3

• Platelet count at least 120,000/mm^3

Hepatic

• Bilirubin no greater than 1.5 mg/dL

• No known Gilbert's disease

Renal

• Creatinine no greater than 1.5 mg/dL

Cardiovascular

• No myocardial infarction within the past 6 months

• No symptomatic heart disease

Pulmonary

• Forced expiratory volume (FEV)_1 at least 1.0 L/sec

• No uncontrolled bronchospasms

• No uncompensated chronic obstructive pulmonary disease

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No pre-existing peripheral neuropathy grade 2 or greater

• No other malignancy within the past 2 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the bladder or cervix

• No other concurrent serious medical illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic therapy

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

• No concurrent intensity-modulated radiotherapy

Surgery

• See Disease Characteristics

Other

• At least 7 days since prior enzyme-inducing anti-convulsant drugs (EIACDs) (e.g., phenytoin, carbamazepine, or phenobarbital) if used on a regular basis for more than 2 weeks

• Less than 2 weeks of regular use of EIACDs does not require a 7-day wash-out period

• At least 14 days since prior Hypericum perforatum (St. John's wort)

• No concurrent EIACDs

• No concurrent amifostine during chemoradiotherapy

• Concurrent gabapentin or other non-EIACDs allowed

Study Design

Allocation: Non-Randomized, 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:
• cisplatin

• irinotecan hydrochloride

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio
United States	Comprehensive Cancer Center at University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Providence Saint Joseph Medical Center - Burbank	Burbank	California
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Sarah Cannon Cancer Center at Parkridge Medical Center	Chattanooga	Tennessee
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	Delaware County Regional Cancer Center at Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	Wendt Regional Cancer Center at Finley Hospital	Dubuque	Iowa
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital	Fort Lauderdale	Florida
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Wayne Radiation Oncology	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	Saint Rose Hospital	Hayward	California
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Memorial Cancer Institute at Memorial Regional Hospital	Hollywood	Florida
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Ella Milbank Foshay Cancer Center at Jupiter Medical Center	Jupiter	Florida
United States	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	Valley Memorial Hospital	Livermore	California
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	Baptist-South Miami Regional Cancer Program	Miami	Florida
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	Tucker Center for Cancer Care at Orange Regional Medical Center	Middletown	New York
United States	Fox Chase Virtua Health Cancer Program - Marlton	Mount Holly	New Jersey
United States	Cottonwood Hospital Medical Center	Murray	Utah
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Highland General Hospital at St. George's University School of Medicine	Oakland	California
United States	Summit Medical Center	Oakland	California
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Albert Einstein Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Mercy Cancer Institute at Mercy Hospital	Pittsburgh	Pennsylvania
United States	AtlantiCare Regional Medical Center	Pomona	New Jersey
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	LDS Hospital	Salt Lake City	Utah
United States	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah
United States	J.C. Robinson, M.D. Regional Cancer Center	San Pablo	California
United States	Dixie Regional Medical Center	St. George	Utah
United States	SUNY Upstate Medical University Hospital	Syracuse	New York
United States	Wilson Medical Center	Wilson	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Langer C, Swann S, Werner-Wasik M, et al.: Phase I study of combination irinotecan and cisplatin and either twice daily thoracic radiation (45Gy) or once daily thoracic radiotherapy (70Gy) in patients with limited small cell lung carcinoma (SCLC): early t

Langer CJ, Swann S, Werner-Wasik M, et al.: Phase I study of irinotecan (Ir) and cisplatin (DDP) in combination with thoracic radiotherapy (RT), either twice daily (45 Gy) or once daily (70 Gy), in patients with limited (Ltd) small cell lung carcinoma (SC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of irinotecan in combination with cisplatin and thoracic radiotherapy (45 Gy BID or 70 Gy daily) by toxicity assessment (Common Toxicity Criteria version 3.0) during acute and late toxicity		From the start of treatment until 90 days	Yes
Secondary	Rate of non-dose limiting toxicity		From start of treatment to the end of follow-up	Yes