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A Randomized Phase II Trial of Cisplatin or Carboplatin With Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

A Randomized Phase II Trial of Cisplatin or Carboplatin With Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer


OBJECTIVES: I. Determine the response rates of gemcitabine and carboplatin vs gemcitabine
and cisplatin in patients with stage IIIB, IV, or recurrent non-small cell lung cancer. II.
Determine the toxicity of these two regimens in this patient population. III. Determine the
time to progression and one year survival of these patients on these regimens.

OUTLINE: This is a randomized study. Patients are stratified by stage of disease and gender.
Patients are randomized to one of two treatment arms. Arm I: Patients receive gemcitabine IV
over 30 minutes on days 1 and 8, followed by carboplatin over 60 minutes on day 1. Arm II:
Patients receive gemcitabine IV over 30 minutes on days 1 and 8, followed by cisplatin IV
over 60 minutes on day 1. Treatment repeats every 3 weeks for up to 8 courses in the absence
of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months,
every two months for 6 months, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this
study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIIB or IV
non-small cell lung cancer (NSCLC) Recurrent NSCLC treated with radiation or surgery
allowed Bidimensionally measurable disease by x-ray, CT scan, MRI, or physical exam
outside of irradiation field No active CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Granulocyte count
greater than 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL
Hematocrit at least 30% Hepatic: Bilirubin no greater than 2 mg/dL PT or aPTT no greater
than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 3 times ULN (5 times
ULN if liver metastases present) Renal: Creatinine no greater than 2 mg/dL Other: Not
pregnant or nursing Fertile patients must use effective contraception during and for 3
months after study No serious concurrent systemic disorder that would preclude study
compliance No active infection No second primary malignancy within the past 5 years,
except: Adequately treated basal cell skin cancer Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy
No concurrent immunotherapy Chemotherapy: No prior chemotherapy No other concurrent
chemotherapy Endocrine therapy: At least 3 weeks since prior endocrine therapy No
concurrent hormonal therapy (except contraceptives and replacement steroids) Radiotherapy:
See Disease Characteristics At least 3 weeks since prior radiotherapy No concurrent
radiotherapy Surgery: See Disease Characteristics Other: At least 4 weeks since other
prior investigational drugs No other concurrent experimental drugs No concurrent
interleukin-11 for patients with cardiac disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Haralambos Raftopoulos, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067444

NCT ID:

NCT00004201

Start Date:

Completion Date:

August 2004

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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