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CompletedPhase 2NCT00033696
Official study title

Combination Chemotherapy and 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 and radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedfilgrastim and carboplatin

Plus 4 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 Jul 19, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?51 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Biological: filgrastim; Drug: carboplatin; Drug: etoposide; Drug: paclitaxel; Drug: topotecan 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→
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
  • Limited stage defined as disease restricted to one hemithorax with regional lymph node metastases including hilar, ipsilateral, and contralateral mediastinal lymph nodes
  • Measurable disease
  • At least 20 mm by conventional techniques OR
  • At least 10 mm by spiral CT scan
  • Lesions not considered measurable include the following:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Abdominal masses not confirmed and followed by imaging techniques
  • Cystic lesions
  • Tumor lesions in a previously irradiated area
  • No clinically suspected or confirmed supraclavicular lymph node metastases
  • No pleural effusions visible on plain chest radiographs, regardless of cytology PATIENT CHARACTERISTICS: Age:
  • 18 and over Performance status:
  • ECOG 0-2 Life expectancy:
  • Not specified Hematopoietic:
  • Granulocyte count at least 1,500/mm3
  • Platelet count at least 100,00/mm3 Hepatic:
  • Bilirubin less than 1.5 mg/dL
  • SGOT less than 2 times upper limit of normal (ULN) Renal:
  • Creatinine no greater than ULN
  • Creatinine clearance no greater than 150 mL/min for men or 130 mL/min for women Other:
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other currently active malignancy except non-melanoma skin cancer
  • Patients must have completed therapy for any other malignancy and be considered to be at less than 30% risk of relapse PRIOR CONCURRENT THERAPY: Biologic therapy:
  • No concurrent filgrastim (G-CSF) during consolidation therapy Chemotherapy:
  • No prior chemotherapy for small cell lung cancer
  • No other concurrent chemotherapy Endocrine therapy:
  • No concurrent hormonal therapy except:
  • Steroids for adrenal failure
  • Hormones for non-disease-related conditions (e.g., insulin for diabetes)
  • Intermittent use of dexamethasone as an antiemetic or as an adjunct to prophylactic cranial irradiation Radiotherapy:
  • See Disease Characteristics
  • No prior chest radiotherapy Surgery:
  • Not specified

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

  • Veterans Affairs Medical Center - BirminghamBirmingham, Alabama
  • University of California San Diego Cancer CenterLa Jolla, California
  • Cedars-Sinai Medical CenterLos Angeles, California
  • Veterans Affairs Medical Center - San FranciscoSan Francisco, California
  • UCSF Cancer Center and Cancer Research InstituteSan Francisco, California
  • CCOP - Christiana Care Health ServicesWilmington, Delaware
  • Lombardi Cancer CenterWashington D.C., District of Columbia
  • Walter Reed Army Medical CenterWashington D.C., District of Columbia
  • CCOP - Mount Sinai Medical CenterMiami Beach, Florida
  • Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois
  • University of Chicago Cancer Research CenterChicago, Illinois
  • CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 19, 2016. Always confirm current availability with the study team.

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