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An Open-Label, Multicenter, Randomized, Phase II Study of Topotecan/Paclitaxel vs Etoposide/Cisplatin as First-Line Therapy for Patients With Extensive Disease Small Cell Lung Cancer

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

An Open-Label, Multicenter, Randomized, Phase II Study of Topotecan/Paclitaxel vs Etoposide/Cisplatin as First-Line Therapy for Patients With Extensive Disease Small Cell Lung Cancer

OBJECTIVES: I. Compare the response rates in patients with extensive stage small cell lung
cancer treated with topotecan and paclitaxel versus etoposide and cisplatin. II. Compare
time to response, response duration, time to progression, and survival in these patients
treated with these regimens. III. Determine the toxicity profiles of these regimens in these
patients. IV. Compare the effects of these regimens on symptoms of disease in these

OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified
according to gender, ECOG performance status (0-1 vs 2), and elevated LDH (absent vs
present). Patients are randomized to one of two treatment arms. Arm I: Patients receive
paclitaxel IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Patients
also receive filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood
counts recover. Arm II: Patients receive cisplatin IV over 3 hours on day 1 and etoposide IV
over 30 minutes on days 1-3. Treatment continues every 21 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity. Patients are followed every 3

PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this

Inclusion Criteria

DISEASE CHARACTERISTICS: Diagnosis of extensive stage small cell lung cancer At least 1
bidimensionally measurable non CNS lesion At least 1 cm in one diameter and at least 2 cm
in another diameter by CT or MRI scan At least 2 cm in two diameters by x-ray, ultrasound,
or for palpable tumor masses by physical exam Measurable skin lesion at least 1 cm in at
least one diameter by photography No symptomatic CNS and/or leptomeningeal metastases
requiring corticosteroid therapy to control symptoms

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: WBC at least 3,500/mm3 Hemoglobin at least 9.0 g/dL
Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin
no greater than 2.0 mg/dL SGOT, SGPT, and alkaline phosphatase no greater than 2 times
upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)
Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min
Cardiovascular: No preexisting cardiac disease No congestive heart failure No cardiac
arrhythmia requiring therapy No myocardial infarction within the past 3 months Other: Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception for 3 months before, during, and for at least 4 weeks after study No active
uncontrolled infection No other concurrent or prior malignancies within the past 5 years
except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the
cervix, or stage I low grade prostate cancer No other severe medical problem or any other
medical condition that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: At least 24
hours since prior radiotherapy if no marked bone marrow suppression expected At least 6
weeks since prior radiotherapy to measurable lesion if evidence of progression Concurrent
radiotherapy for bone pain control allowed Surgery: At least 3 weeks since prior surgery
Other: At least 30 days or 5 half lives (whichever is longer) since prior investigational
drug No other concurrent investigational drugs

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Nathan Levitan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

October 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Ireland Cancer Center Cleveland, Ohio  44106-5065