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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00087048
• Other study ID #: CDR0000372872
• Secondary ID: CASE-HFHS-1503HF
• Status: Terminated
• Phase: Phase 2
• First received: July 8, 2004
• Last updated: March 21, 2016
• Start date: April 2004
• Est. completion date: February 2006

Study information

• Verified date: March 2016
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 2 months since prior investigational agent

• No other concurrent investigational agent

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• topotecan hydrochloride

Locations

Country	Name	City	State
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival			No
Secondary	Safety and toxic effects			Yes
Secondary	Recurrence-free survival			No
Secondary	Time to response and tumor response			No
Secondary	Quality of life			No