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

Sponsor:	Radiation Therapy Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00059761

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: cisplatin Drug: irinotecan hydrochloride Radiation: radiation therapy	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Irinotecan U 101440E Irinotecan hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Response rate, time to progression, and survival at median and 2 years [ Designated as safety issue: No ]

Study Start Date:

March 2003

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059761

Show 49 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Corey J. Langer, MD	Fox Chase Cancer Center
Investigator:	Maria Werner-Wasik, MD	Kimmel Cancer Center (KCC)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

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.

ClinicalTrials.gov Identifier:	NCT00059761 History of Changes
Other Study ID Numbers:	CDR0000269348, RTOG-0241
Study First Received:	May 6, 2003
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

limited stage small cell lung cancer

Additional relevant MeSH terms:

Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Irinotecan
Cisplatin

Camptothecin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012