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Induction Cisplatin/Irinotecan Followed By Combination Carboplatin, Etoposide And Chest Radiotherapy In Limited Stage Small Cell Lung Cancer: A Phase II Study

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Trial Conditions
  • Lung Cancer
What is the purpose of this trial?

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.

Date & Status


Who can Participate?


18 and older



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

Gender: Both
Steward Physician(s)
  • Michael J. Kelley, MD
  • Saint Anne's Hospital - Completed
Trial Interventions
  • carboplatin
  • cisplatin
  • etoposide
  • irinotecan hydrochloride
  • radiation therapy
Physician Researcher

Investigator Name:

  • Michael J. Kelley, MD

Other Information

Sponsor: Alliance for Clinical Trials in Oncology
Phase: Phase 2
Trial ID: NCT00072527
Volunteers:  Not Accepting Healthy Volunteers

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