CompletedPhase 2NCT00072527
Official study title

Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Study summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, irinotecan, carboplatin, and etoposide, 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 II trial to study the effectiveness of cisplatin and irinotecan followed by carboplatin, etoposide, 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 studiedcarboplatin and cisplatin

Plus 3 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 6, 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?76 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: carboplatin; Drug: cisplatin; Drug: etoposide; 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.

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
  • 1. Histologically or cytologically documented small cell lung cancer of limited stage. 1.1 Limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal lymph nodes. 1.2 Although they are usually defined as having limited stage small cell lung cancer, because of concern about the volume of the radiation field that would be required, patients with clinically suspected or confirmed supraclavicular lymph node metastases, patients with pathologically enlarged contralateral hilar lymph nodes, and patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not, are NOT eligible. 2. All Patients must have Measurable Disease 2.1 Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan. 2.2 Pleural/pericardial effusions are not considered measurable. 3. Age ≥18 4. ECOG Performance status 0-2. 5. Prior Treatment - No prior chemotherapy or radiotherapy for SCLC. 6. No "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse. 7. Non-pregnant and non-nursing because of significant risk to the fetus/infant. 8. Required Initial Laboratory Values
  • Granulocytes ≥1,500/µl
  • Platelets ≥100,000/µl
  • Serum Creatinine ≤ULN
  • Bilirubin \<1.5 mg/dl
  • SGOT (AST) \<2 x ULN

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

  • Beebe Medical CenterLewes, Delaware
  • CCOP - Christiana Care Health ServicesNewark, Delaware
  • St. Francis HospitalWilmington, Delaware
  • Walter Reed Army Medical CenterWashington D.C., District of Columbia
  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia
  • St. Joseph Medical CenterBloomington, Illinois
  • Graham HospitalCanton, Illinois
  • Memorial HospitalCarthage, Illinois
  • University of Chicago Cancer Research CenterChicago, Illinois
  • Eureka HospitalEureka, Illinois
  • Galesburg ClinicGalesburg, Illinois
  • Galesburg Cottage HospitalGalesburg, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 6, 2016. Always confirm current availability with the study team.

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