NCT00294190

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2006

Typical duration for phase_2

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

December 10, 2012

Status Verified

May 1, 2011

Enrollment Period

1.6 years

First QC Date

February 16, 2006

Last Update Submit

December 6, 2012

Conditions

Small Cell Lung CancerCarcinoma, Small Cell

Keywords

Lung CancerExtensive stageSmall Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

    18 months

Secondary Outcomes (4)

  • overall toxicity

    18 months

  • time to progression

    18 months

  • duration of response

    18 months

  • overall survival

    18 months

Study Arms (1)

Topotecan

EXPERIMENTAL
Drug: Topotecan

Interventions

TopotecanDRUG

Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break.

Also known as: Hycamtin
Topotecan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Northeast Arkansas Clinic

Jonesboro, Arkansas, 72401, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Watson Clinic Center for Cancer Care and Research

Lakeland, Florida, 33805, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, 40207, United States

Location

Hematology Oncology Life Center

Alexandria, Louisiana, 71301, United States

Location

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

Methodist Cancer Center

Omaha, Nebraska, 68114, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

Related Publications (1)

  • 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.

    PMID: 21663862DERIVED

MeSH Terms

Conditions

Small Cell Lung CarcinomaCarcinoma, Small CellLung Neoplasms

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • David R. Spigel, MD

    SCRI Development Innovations, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2006

First Posted

February 20, 2006

Study Start

February 1, 2006

Primary Completion

September 1, 2007

Study Completion

July 1, 2009

Last Updated

December 10, 2012

Record last verified: 2011-05

Locations

US(13)