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Neoadjuvant Chemoradiotherapy Followed By Surgery in Treating Patients With Limited-Stage Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cisplatin
irinotecan hydrochloride
conventional surgery
neoadjuvant therapy
radiation therapy
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring limited stage small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell lung cancer Limited stage disease (clinical stage I-IIIA) and meets the following criteria: Confined to 1 hemithorax No T4 disease based on malignant pleural effusion No N3 disease based on contralateral hilar or supraclavicular involvement Contralateral mediastinal (N3) nodes greater than 1.5 cm on CT scan must be biopsied to rule out pathologic involvement Measurable or evaluable disease Tumor must be able to be encompassed by limited radiotherapy field without significantly compromising pulmonary function No pleural effusion visible on chest x-ray (regardless of cytology) No prior complete tumor resection PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 70-100% Life expectancy Not specified Hematopoietic Absolute granulocyte count at least 1,800/mm^3 Platelet count at least 100,000/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 Calcium less than 12.0 mg/dL Cardiovascular No myocardial infarction within the past 6 months No congestive heart failure No uncontrolled arrhythmias No active unstable angina Pulmonary Calculated postoperative FEV_1 at least 800 cc No chronic obstructive pulmonary disease with FEV_1 no greater than 1 L or uncontrolled bronchospasm in the unaffected lung Other Not pregnant Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other noninvasive malignancy No history of seizures No history of uncontrolled psychiatric illness that would preclude giving informed consent or complying with study No active or uncontrolled infection No uncontrolled diabetes mellitus (random blood sugar at least 250 mg/dL) No other concurrent serious medical illness HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior irinotecan No prior topotecan Endocrine therapy Not specified Radiotherapy No prior radiotherapy to the chest or other areas containing 30% or more of marrow-bearing bone Surgery See Disease Characteristics Other No concurrent phenytoin, phenobarbital, or other antiepileptic prophylactic drugs No concurrent amifostine

Sites / Locations

  • Fox Chase Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 5, 2003
Last Updated
February 11, 2010
Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00062322
Brief Title
Neoadjuvant Chemoradiotherapy Followed By Surgery in Treating Patients With Limited-Stage Small Cell Lung Cancer
Official Title
Phase I Study of Preoperative Chemo/Radiation (Concurrent Irinotecan/Cisplatin/RT) Followed by Surgery in Limited Stage Small Cell Lung Cancer (SCLC-LS)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin 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. Irinotecan and cisplatin may also make the tumor cells more sensitive to radiation therapy. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: This phase I trial is studying the side effects of neoadjuvant radiation therapy given together with irinotecan and cisplatin followed by surgery in treating patients with limited-stage small cell lung cancer.
Detailed Description
OBJECTIVES: Determine the safety and feasibility of neoadjuvant chemoradiotherapy with irinotecan and cisplatin followed by surgery in patients with limited stage small cell lung cancer. Determine the pathologic complete response rate of patients treated with this regimen. Correlate the level of vascular endothelial growth factor with treatment response and disease outcome in patients treated with this regimen. Correlate genetic polymorphisms in cytochrome P450 1A1, glutathione S-transferase M1 and P1, myeloperoxidase, and NAD(p)H: quinone oxidoreductase with treatment response and disease outcome in patients treated with this regimen. OUTLINE: This is a pilot study. Induction chemotherapy: Patients receive cisplatin IV over 1 hour on day 1 and irinotecan IV over 90 minutes on days 1 and 8. Chemoradiotherapy: Beginning on day 21, patients receive chemoradiotherapy comprising radiotherapy once daily, 5 days a week for 4 weeks and then twice daily for 4 days. Patients also receive cisplatin IV and irinotecan IV over 30-60 minutes once weekly concurrently with radiotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. At the completion of chemoradiotherapy, patients are evaluated for surgery. Patients who are candidates for surgery receive one additional course of cisplatin IV and irinotecan IV. Patients who are not candidates for surgery receive radiotherapy twice daily for 4 days and cisplatin IV and irinotecan IV as in chemoradiotherapy. Surgery: Approximately 2-4 weeks after the last dose of chemotherapy, patients undergo surgery. Patients are followed every 4 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
limited stage small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell lung cancer Limited stage disease (clinical stage I-IIIA) and meets the following criteria: Confined to 1 hemithorax No T4 disease based on malignant pleural effusion No N3 disease based on contralateral hilar or supraclavicular involvement Contralateral mediastinal (N3) nodes greater than 1.5 cm on CT scan must be biopsied to rule out pathologic involvement Measurable or evaluable disease Tumor must be able to be encompassed by limited radiotherapy field without significantly compromising pulmonary function No pleural effusion visible on chest x-ray (regardless of cytology) No prior complete tumor resection PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 70-100% Life expectancy Not specified Hematopoietic Absolute granulocyte count at least 1,800/mm^3 Platelet count at least 100,000/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 Calcium less than 12.0 mg/dL Cardiovascular No myocardial infarction within the past 6 months No congestive heart failure No uncontrolled arrhythmias No active unstable angina Pulmonary Calculated postoperative FEV_1 at least 800 cc No chronic obstructive pulmonary disease with FEV_1 no greater than 1 L or uncontrolled bronchospasm in the unaffected lung Other Not pregnant Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other noninvasive malignancy No history of seizures No history of uncontrolled psychiatric illness that would preclude giving informed consent or complying with study No active or uncontrolled infection No uncontrolled diabetes mellitus (random blood sugar at least 250 mg/dL) No other concurrent serious medical illness HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior irinotecan No prior topotecan Endocrine therapy Not specified Radiotherapy No prior radiotherapy to the chest or other areas containing 30% or more of marrow-bearing bone Surgery See Disease Characteristics Other No concurrent phenytoin, phenobarbital, or other antiepileptic prophylactic drugs No concurrent amifostine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Feigenberg, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Neoadjuvant Chemoradiotherapy Followed By Surgery in Treating Patients With Limited-Stage Small Cell Lung Cancer

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