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CompletedPhase 1NCT00059761
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcisplatin and irinotecan hydrochloride

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 17, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?49 U.S. locations

Locations may change over time.

Who runs it?Radiation Therapy Oncology Group

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Radiation Therapy Oncology Group
Interventions being studied
Drug: cisplatin; Drug: irinotecan hydrochloride; Radiation: radiation therapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
Treatment approach
Chemotherapy→Radiation therapy→Surgery→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama
  • Providence Saint Joseph Medical Center - BurbankBurbank, California
  • Saint Rose HospitalHayward, California
  • Valley Memorial HospitalLivermore, California
  • Highland General Hospital at St. George's University School of MedicineOakland, California
  • CCOP - Bay Area Tumor InstituteOakland, California
  • Summit Medical CenterOakland, California
  • J.C. Robinson, M.D. Regional Cancer CenterSan Pablo, California
  • CCOP - Christiana Care Health ServicesNewark, Delaware
  • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida
  • University of Florida Shands Cancer CenterGainesville, Florida
  • Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 17, 2015. Always confirm current availability with the study team.

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