Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer

A Phase II Study Of Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer

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.

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Cancer; Carcinoma, Small Cell
• Intervention / Treatment: Drug: Topotecan

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.)

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Northeast Arkansas Clinic
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists
    • Lakeland, Florida, United States, 33805
      • Watson Clinic Center for Cancer Care and Research
    • Orlando, Florida, United States, 32804
      • Florida Hospital Cancer Institute
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Consultants in Blood Disorders and Cancer
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Hematology Oncology Life Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Grand Rapids Clinical Oncology Program
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Methodist Cancer Center
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Oncology Hematology Associates
    • Nashville, Tennessee, United States, 37023
      • Tennessee Oncology, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topotecan	Drug: Topotecan; Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break.; Other Names: Hycamtin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall response rate	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	18 months
time to progression	18 months
overall toxicity	18 months
duration of response	18 months

Collaborators and Investigators

• Sponsor: SCRI Development Innovations, LLC
• Collaborators: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: February 16, 2006
• First Submitted That Met QC Criteria: February 16, 2006
• First Posted (Estimate): February 20, 2006

Study Record Updates

• Last Update Posted (Estimate): December 10, 2012
• Last Update Submitted That Met QC Criteria: December 6, 2012
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Lung Cancer; Small Cell Lung Cancer; Extensive stage
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Small Cell; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Topotecan
• Other Study ID Numbers: SCRI LUN 120; 105642