Clinical trial NCT00294190: Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
Official title: A Phase II Study Of Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Carcinoma, Small Cell
Keywords: Lung Cancer
Extensive stage
Small Cell Lung Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2006-02-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This proposed phase II trial will investigate weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added toxicity. To help ameliorate the fatigue, planned rest weeks will be incorporated into the schedule. This trial will be the first clinical trial to evaluate a higher dose of weekly topotecan in the treatment of extensive-stage SCLC.

Detailed description: All patients will receive weekly topotecan.

Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break. Cycles are repeated every 8 weeks, for 3 cycles. Restaging studies will be performed every cycle (or 8 weeks.)

Eligibility criteria: Inclusion Criteria:

* Extensive small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen
* Measurable or evaluable disease
* Able to perform activities of daily living with minimal assistance
* Adequate bone marrow, liver and kidney function
* May have received no more than 3 previous courses of radiation therapy
* Give written informed consent prior to study entry

Exclusion Criteria:

* Patients with limited stage disease
* History of a prior malignancy within three years
* Female patients who are pregnant or are breast feeding
* Significant history of uncontrolled cardiac disease
* Myocardial infarction or stroke within six months
* Symptomatic peripheral vascular disease
* CNS involvement
* Serious active infection or underlying medical condition

Primary outcomes:
measure: Overall response rate
timeFrame: 18 months
Secondary outcomes:
measure: overall toxicity
timeFrame: 18 months
measure: time to progression
timeFrame: 18 months
measure: duration of response
timeFrame: 18 months
measure: overall survival
timeFrame: 18 months
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Northeast Arkansas Clinic
state: Arkansas
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center for Cancer Care and Research
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Louisville
country: United States
facility: Consultants in Blood Disorders and Cancer
state: Kentucky
city: Alexandria
country: United States
facility: Hematology Oncology Life Center
state: Louisiana
city: Grand Rapids
country: United States
facility: Grand Rapids Clinical Oncology Program
state: Michigan
city: Omaha
country: United States
facility: Methodist Cancer Center
state: Nebraska
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology Associates
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: David R. Spigel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spigel DR, Greco FA, Burris HA 3rd, Shipley DL, Clark BL, Whorf RC, Arrowsmith ER, Hainsworth JD. A phase II study of higher dose weekly topotecan in relapsed small-cell lung cancer. Clin Lung Cancer. 2011 May;12(3):187-91. doi: 10.1016/j.cllc.2011.03.016. Epub 2011 Apr 28.