Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer

Case Comprehensive Cancer Center (Case CCC)

Status and phase

Terminated

Phase 2

Conditions

Lung Cancer

Treatments

Drug: topotecan hydrochloride

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00087048

CASE-HFHS-1503

CWRU-050308

CDR0000372872

HFH-HFHS-1503

HFH-HFHS-0205

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well high-dose topotecan works as second-line therapy in treating patients with recurrent extensive-stage small cell lung cancer.

Full description

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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-central nervous system (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

Eastern Cooperative Oncology Group (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

Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (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