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Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Mediastinal Neoplasms

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Trial Information

Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the overall response rate of patients treated with at least two cycles of this regimen

Outcome Time Frame:

3 years

Principal Investigator

Raza Khan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Aultman Hospital

Authority:

United States: Institutional Review Board

Study ID:

Hycamtin study #102143

NCT ID:

NCT00315211

Start Date:

November 2004

Completion Date:

June 2007

Related Keywords:

  • Mediastinal Neoplasms
  • Small Cell Lung Cancer Recurrent
  • Neoplasms
  • Lung Neoplasms
  • Mediastinal Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Aultman HospitalCanton, Ohio  44710