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Phase I/IIA Study of Sequential Ifosfamide and Topotecan in Patients With Small Cell Lung Cancer


Phase 1/Phase 2
N/A
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Phase I/IIA Study of Sequential Ifosfamide and Topotecan in Patients With Small Cell Lung Cancer


OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of topotecan
when combined with ifosfamide in patients with limited or extensive stage small cell lung
cancer. II. Determine the pharmacokinetics of topotecan and correlate with toxicity or tumor
response in these patients. III. Determine the effect of topotecan on apoptosis in tumor
tissues and correlate the apoptosis-inducing effects with antitumor effects of topotecan in
these patients. IV. Determine the response rate, time to progression, and survival of
chemotherapy naive limited or extensive stage small cell lung cancer patients treated with
ifosfamide and topotecan and then crossover consolidation/salvage therapy with carboplatin
and etoposide. V. Determine the response rate, time to progression, and survival of
pretreated limited or extensive stage small cell lung cancer patients treated with
ifosfamide and topotecan as salvage therapy.

OUTLINE: This is a dose escalation study of topotecan (phase I). Patients are stratified by
disease stage (extensive vs limited) and prior chemotherapy (naive vs pretreated) in phase
II. Induction therapy: Patients receive topotecan IV over 72 hours and ifosfamide IV over 30
minutes every 3 weeks. Chemotherapy naive patients with complete or partial response after 3
courses, stable disease after 2 courses, or progressive disease at any time receive
consolidation/salvage chemotherapy. Pretreated patients continue on induction regimen for a
minimum of 6 courses unless disease progression or unacceptable toxicity. Phase I: Cohorts
of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD)
is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients
experience dose limiting toxicity. Salvage chemotherapy: Patients with extensive stage
disease receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 45 minutes on
days 1, 2, and 3. Treatment repeats every 3 weeks for up to 4 to 6 courses. Patients with
limited stage disease undergoing chest irradiation receive treatment every 28 days for the
first course. Patients are followed every 2 months for 1 year, every 3 months for 1 year,
and then every 4 months thereafter.

PROJECTED ACCRUAL: Approximately 15-20 patients will be accrued for phase I and
approximately 35 patients will be accrued for phase II of this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed limited or extensive
stage small cell lung cancer Measurable or evaluable disease No uncontrolled brain
metastases

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Karnofsky 60-100%
Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal:
Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Fertile patients must
use effective contraception No other malignancy within the past 5 years, except:
Nonmelanomatous skin cancer Carcinoma in situ of the cervix No significant active
infection

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1
prior first line chemotherapy regimen Endocrine therapy: Not specified Radiotherapy: No
prior radiotherapy (except brain irradiation) Surgery: Recovered from recent surgery

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose and dose limiting toxicity of topotecan when combined with ifosfamide in patients with limited or extensive stage small cell lung cancer

Outcome Time Frame:

from baseline up to 6 courses of treatment

Safety Issue:

Yes

Principal Investigator

Francisco Robert, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000067427

NCT ID:

NCT00004186

Start Date:

December 1996

Completion Date:

December 2004

Related Keywords:

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

Name

Location

University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294