CompletedPhase 2NCT00005972
Official study title

Combination Chemotherapy in Treating Patients With Recurrent or Refractory 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have recurrent or refractory small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedgemcitabine hydrochloride and irinotecan hydrochloride

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Recurrent or relapsed · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 14, 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?50 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
Drug: gemcitabine hydrochloride; Drug: irinotecan hydrochloride
02
Explore related studies

How this study is categorized

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

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 recurrent or refractory small cell lung cancer Measurable disease At least 20 mm with conventional techniques OR At least 10 mm with spiral CT scan The following are not considered measurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging techniques Cystic lesions Tumor lesions situated in a previously irradiated area Known CNS metastases allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CTC 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No prior or concurrent malignancy in past 5 years except curatively treated carcinoma in situ of the cervix, breast, or basal cell or squamous cell carcinoma of the skin PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1 prior chemotherapy or chemoradiotherapy regimen No prior gemcitabine or irinotecan Endocrine therapy: Not specified Radiotherapy: No more than 1 prior chemoradiotherapy regimen At least 2 weeks since prior cranial radiotherapy for CNS metastases No concurrent cranial 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
  • 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
  • University of Illinois at Chicago Health Sciences CenterChicago, Illinois
  • Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois
  • University of Chicago Cancer Research CenterChicago, Illinois
  • Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 14, 2016. Always confirm current availability with the study team.

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