ClinicalTrials.gov
ClinicalTrials.gov Menu

Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00315211
Recruitment Status : Terminated (Slow Accrual)
First Posted : April 18, 2006
Last Update Posted : August 20, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Aultman Health Foundation

Brief Summary:

The purposes of this study are:

  • To determine the overall response rate of patients treated with at least 2 cycles of this regimen.
  • To determine the feasibility and toxicity of the combination of topotecan and docetaxel.

Condition or disease Intervention/treatment Phase
Mediastinal Neoplasms Drug: Intravenous Topotecan Drug: Intravenous Docetaxel Phase 2

Detailed Description:

The main objective of this study was to determine the overall response rate of patients treated with at least 2 cycles of topotecan and docetaxel. The secondary objectives were to determine the feasibility and toxicities of this combination. The final secondary objective is overall survival for patients that received 2 or more cycles.

Methods: Eligible pts with recurrent small cell lung cancer had to be at least 3 months from initial treatment. Pts received Docetaxel 30 mg/m2 IV followed by Topotecan 3 mg/m2 IV Days 1 and 8 of a 21 day cycle. Disease assessment was done every 2 cycles. Toxicity was measured each cycle.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer
Study Start Date : November 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : November 8, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Arm A
Weekly intravenous topotecan with intravenous docetaxel
Drug: Intravenous Topotecan
Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days
Other Name: Hycamtin

Drug: Intravenous Docetaxel
Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 & 8 of a 21 day cycle
Other Name: Taxotere




Primary Outcome Measures :
  1. To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel [ Time Frame: 3 years ]
    To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recurred greater than 90 days after initial treatment
  • At least 1 measurable lesion
  • Only 1 prior chemotherapy
  • Must be over 18 years of age
  • ECOG performance status of 0 - 2
  • Adequate hematologic, renal, and hepatic function

Exclusion Criteria:

  • No prior use of topotecan, docetaxel, or irinotecan
  • No symptomatic brain metastases
  • History of cardiac arrhythmias, congestive heart failure, stroke, or embolic events
  • No prior investigational agents within 1 month prior
  • Lung cancer of mixed histology
  • Known uncontrolled seizure disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315211


Locations
United States, Ohio
Aultman Hospital
Canton, Ohio, United States, 44710
Sponsors and Collaborators
Aultman Health Foundation
GlaxoSmithKline
Investigators
Principal Investigator: Raza Khan, MD Aultman Hospital

Responsible Party: Aultman Health Foundation
ClinicalTrials.gov Identifier: NCT00315211     History of Changes
Other Study ID Numbers: Hycamtin study #102143
Lung 01 ( Other Identifier: Aultman Health Foundation )
First Posted: April 18, 2006    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018

Keywords provided by Aultman Health Foundation:
Small Cell Lung Cancer Recurrent

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Mediastinal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Mediastinal Diseases
Thoracic Diseases
Docetaxel
Topotecan
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors