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The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer


OBJECTIVES:

Primary

- Determine the overall survival of patients with recurrent extensive stage small cell
lung cancer treated with high-dose topotecan hydrochloride.

Secondary

- Determine the safety and toxic effects of this drug in these patients.

- Determine the recurrence-free survival of patients treated with this drug.

- Determine time to response and tumor response in patients treated with this drug.

- Determine the quality of life of patients treated with this drug.

OUTLINE: This is a non-randomized, multicenter study.

Patients receive high-dose topotecan hydrochloride IV over 30 minutes on days 1, 8, 15, 22,
29, and 36. Treatment repeats every 56 days for 4 courses in the absence of disease
progression or unacceptable toxicity.

Quality of life is assessed at baseline, day 1 of each course (except course 1), at the end
of study treatment, and then every 3 months thereafter.

Patients are followed at 7-14 days and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed small cell lung cancer (SCLC)

- Recurrent extensive stage disease

- No mixed histology

- Measurable disease

- At least 1 bidimensionally measurable, non-CNS, indicator lesion confirmed by CT
scan or MRI

- Sensitive disease

- Responded to prior first-line therapy AND relapsed ≥ 60 days after response (90
days after initiation of first-line therapy)

- Eligible for high-dose chemotherapy

- No symptomatic brain metastases affecting performance status

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 2 months

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9.0 g/dL

- Hematocrit > 35% (without transfusion)

Hepatic

- SGOT and SGPT ≤ 2 times normal*

- Alkaline phosphatase ≤ 2 times normal*

- Bilirubin ≤ 2.0 mg/dL

- Albumin > 2.5 g/dL

- Hepatitis B surface antigen negative

- No significant hepatic disease NOTE: *≤ 5 times upper limit of normal if liver
metastases are present

Renal

- Creatinine clearance ≥ 40 mL/min

Cardiovascular

- No history of cardiac arrhythmias

- No congestive heart failure

- No ischemic heart disease

- No stroke or other embolic disease requiring daily treatment that would preclude
study participation

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study
participation

- HIV negative

- No known seizure disorder

- No active infection requiring systemic therapy within the past 2 weeks

- No known hypersensitivity to topotecan hydrochloride

- No medical or psychiatric condition that would preclude study participation

- No other malignancy except adequately treated basal cell or squamous cell skin
cancer, carcinoma in situ of the cervix, or stage A low-grade prostate cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- More than 4 weeks since prior antineoplastic and/or myelosuppressive chemotherapy

- No more than 1 prior chemotherapy regimen (except for adjuvant chemotherapy) for SCLC

- No prior topotecan hydrochloride

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- More than 2 months since prior investigational agent

- No other concurrent investigational agent

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:

No

Principal Investigator

Afshin Dowlati, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000372872

NCT ID:

NCT00087048

Start Date:

April 2004

Completion Date:

Related Keywords:

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

Name

Location

Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202