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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
topotecan hydrochloride
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer, recurrent small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Josephine Ford Cancer Center at Henry Ford Hospital
  • Case Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Safety and toxic effects
Recurrence-free survival
Time to response and tumor response
Quality of life

Full Information

First Posted
July 8, 2004
Last Updated
March 21, 2016
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00087048
Brief Title
Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer
Official Title
The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
April 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
extensive stage small cell lung cancer, recurrent small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride
Primary Outcome Measure Information:
Title
Overall survival
Secondary Outcome Measure Information:
Title
Safety and toxic effects
Title
Recurrence-free survival
Title
Time to response and tumor response
Title
Quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 Not specified Radiotherapy Not specified Surgery Not specified Other More than 2 months since prior investigational agent No other concurrent investigational agent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afshin Dowlati, MD
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Josephine Ford Cancer Center at Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

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

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