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

NCT ID: NCT00087048

Last Updated: 2016-03-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2006-02-28

Brief Summary

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.

Detailed 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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

topotecan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 2 months since prior investigational agent
• No other concurrent investigational agent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Afshin Dowlati, MD

Role: STUDY_CHAIR

Case Comprehensive Cancer Center

Locations

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, United States

Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CASE-HFHS-1503

Identifier Type: -

Identifier Source: secondary_id

HFH-HFHS-1503

Identifier Type: -

Identifier Source: secondary_id

HFH-HFHS-0205

Identifier Type: -

Identifier Source: secondary_id

CWRU-050308

Identifier Type: -

Identifier Source: secondary_id

CDR0000372872

Identifier Type: -

Identifier Source: org_study_id