NCT00062322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_1 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2003

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

February 12, 2010

Status Verified

February 1, 2010

First QC Date

June 5, 2003

Last Update Submit

February 11, 2010

Conditions

Lung Cancer

Keywords

limited stage small cell lung cancer

Interventions

cisplatinDRUG
irinotecan hydrochlorideDRUG
conventional surgeryPROCEDURE
neoadjuvant therapyPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

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

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

CisplatinIrinotecanNeoadjuvant TherapyRadiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCamptothecinAlkaloidsHeterocyclic CompoundsCombined Modality TherapyTherapeutics

Study Officials

  • Steven Feigenberg, MD

    Fox Chase Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 5, 2003

First Posted

June 6, 2003

Study Start

February 1, 2003

Study Completion

October 1, 2009

Last Updated

February 12, 2010

Record last verified: 2010-02

Locations

US(1)