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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

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed small cell lung cancer (SCLC)

- Limited stage disease, defined as the following:

- Disease restricted to 1 hemithorax with regional lymph node metastases,
including hilar, ipsilateral, or contralateral mediastinal lymph nodes

- No clinically suspected or confirmed supraclavicular lymph node metastases

- No pathologically enlarged contralateral hilar lymph nodes

- No pleural effusions that are visible on plain chest radiographs, whether
they are cytologically positive or negative

- Unidimensionally measurable disease

- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

- Pleural/pericardial effusions are not considered measurable

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin less than 1.5 mg/dL

- AST less than 2 times upper limit of normal

Renal

- Creatinine no greater than 2.0 mg/dL

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No "currently active" second malignancy except nonmelanoma skin cancer

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

- No prior chemotherapy for SCLC

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent hormonal therapy except the following:

- Steroids for adrenal failure

- Hormones administered for non-disease-related conditions (e.g., insulin for
diabetes)

- Intermittent dexamethasone as an antiemetic or adjunct to prophylactic cranial
radiotherapy

Radiotherapy

- See Endocrine therapy

- No prior radiotherapy for SCLC

- No concurrent intensity-modulated radiotherapy

Surgery

- Not specified

Gender: Both
Steward Physician(s)
  • Michael J. Kelley, MD
Facilities
  • Saint Anne's Hospital - Active, not recruiting
Trial Interventions
Drug
  • carboplatin
  • cisplatin
  • etoposide
  • irinotecan hydrochloride
Radiation
  • radiation therapy
Physician Researcher

Investigator Name:

  • Michael J. Kelley, MD

Other Information

Sponsor: Cancer and Leukemia Group B
Phase: Phase 2
Trial ID: NCT00072527
Volunteers:  Not Accepting Healthy Volunteers

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