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

NCT00059761 | Completed Phase 1 DMC

• 2 other identifiers: RTOG-0241CDR0000269348
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 49

Brief 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.

Conditions

Lung Cancer

Keywords

limited stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Rate of non-dose limiting toxicity

  From start of treatment to the end of follow-up

Study Arms (6)

Sequence A: Level 1

EXPERIMENTAL

Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID

Drug: cisplatin; Drug: irinotecan hydrochloride; Radiation: radiation therapy

Sequence B: Level 1

EXPERIMENTAL

Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily

Drug: cisplatin; Drug: irinotecan hydrochloride; Radiation: radiation therapy

Sequence A: Level 2

EXPERIMENTAL

Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID

Drug: cisplatin; Drug: irinotecan hydrochloride; Radiation: radiation therapy

Sequence B: Level 2

EXPERIMENTAL

Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily

Drug: cisplatin; Drug: irinotecan hydrochloride; Radiation: radiation therapy

Sequence A: Level 3

EXPERIMENTAL

Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID

Drug: cisplatin; Drug: irinotecan hydrochloride; Radiation: radiation therapy

Sequence B: Level 3

EXPERIMENTAL

Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily

Drug: cisplatin; Drug: irinotecan hydrochloride; Radiation: radiation therapy

Interventions

cisplatin DRUG

Sequence A: Level 1; Sequence A: Level 2; Sequence A: Level 3; Sequence B: Level 1; Sequence B: Level 2; Sequence B: Level 3

irinotecan hydrochloride DRUG

Sequence A: Level 1; Sequence A: Level 2; Sequence A: Level 3; Sequence B: Level 1; Sequence B: Level 2; Sequence B: Level 3

radiation therapy RADIATION

Sequence A: Level 1; Sequence A: Level 2; Sequence A: Level 3; Sequence B: Level 1; Sequence B: Level 2; Sequence B: Level 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (49)

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Providence Saint Joseph Medical Center - Burbank

Burbank, California, 91505, United States

Location

Saint Rose Hospital

Hayward, California, 94545, United States

Location

Valley Memorial Hospital

Livermore, California, 94550, United States

Location

Highland General Hospital at St. George's University School of Medicine

Oakland, California, 94602, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Summit Medical Center

Oakland, California, 94609, United States

Location

J.C. Robinson, M.D. Regional Cancer Center

San Pablo, California, 94806, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

University of Florida Shands Cancer Center

Gainesville, Florida, 32610, United States

Location

Memorial Cancer Institute at Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

Ella Milbank Foshay Cancer Center at Jupiter Medical Center

Jupiter, Florida, 33458, United States

Location

Baptist-South Miami Regional Cancer Program

Miami, Florida, 33176, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Wendt Regional Cancer Center at Finley Hospital

Dubuque, Iowa, 52001, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

Location

Fox Chase Virtua Health Cancer Program - Marlton

Mount Holly, New Jersey, 08060, United States

Location

AtlantiCare Regional Medical Center

Pomona, New Jersey, 08240, United States

Location

Tucker Center for Cancer Care at Orange Regional Medical Center

Middletown, New York, 10940, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Wayne Radiation Oncology

Goldsboro, North Carolina, 27534, United States

Location

Wilson Medical Center

Wilson, North Carolina, 27893, United States

Location

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Delaware County Regional Cancer Center at Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141, United States

Location

Mercy Cancer Institute at Mercy Hospital

Pittsburgh, Pennsylvania, 15219, United States

Location

Bon Secours St. Francis Health System

Greenville, South Carolina, 29601, United States

Location

Greenville Hospital System Cancer Center

Greenville, South Carolina, 29605, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

Sarah Cannon Cancer Center at Parkridge Medical Center

Chattanooga, Tennessee, 37404, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030, United States

Location

Cottonwood Hospital Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84603, United States

Location

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, 84106, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center

St. George, Utah, 84770, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Related Publications (2)

• 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 (SCLC): early analysis of RTOG 0241. [Abstract] J Clin Oncol 24 (Suppl 18): A-7058, 378s, 2006.

  RESULT

• 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 toxicity analysis of RTOG 0241. [Abstract] Lung Cancer 49 (Suppl 2): A-P-777, S323, 2005.

  RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Cisplatin; Irinotecan; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Camptothecin; Alkaloids; Heterocyclic Compounds; Therapeutics

Study Officials

• Corey J. Langer, MD

  Fox Chase Cancer Center

  STUDY CHAIR

• Maria Werner-Wasik, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2003
• First Posted: May 7, 2003
• Study Start: March 1, 2003
• Primary Completion: March 1, 2009
• Study Completion: November 1, 2013
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

US (49)