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Phase II Study to Determine the Efficacy of OSI-211 (Liposomal Lurtotecan) Given on Days 1, 2 & 3 Every 3 Weeks in Patients With Recurrent Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
SCLC, Carcinoma, Small Cell

Thank you

Trial Information

Phase II Study to Determine the Efficacy of OSI-211 (Liposomal Lurtotecan) Given on Days 1, 2 & 3 Every 3 Weeks in Patients With Recurrent Small Cell Lung Cancer


Inclusion Criteria:



- Confirmed recurrent small cell lung cancer.

- One prior treatment of chemotherapy.

- At least three weeks since last chemotherapy treatment and recovery from any related
side effects.

- At least three weeks since last chest radiotherapy and at least 10 days since head
irradiation and recovery from acute side effects.

- At least one target tumor less than or equal to 20 mm (or less than or equal to 10 mm
on spiral CT-scan).

- If a patient has had previous documented Central Nervous System (CNS) involvement,
only controlled disease is acceptable.

Exclusion Criteria:

- Superior vena cava syndrome.

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

Authority:

United States: Food and Drug Administration

Study ID:

110-12

NCT ID:

NCT00046787

Start Date:

September 2002

Completion Date:

February 2003

Related Keywords:

  • SCLC
  • Carcinoma, Small Cell
  • Small Cell Lung Cancer
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Carcinoma, Small Cell

Name

Location
University of Colorado Health Sciences Center Denver, Colorado  80262
Arizona Clinical Research Center, Inc. Tucson, Arizona  85712
Baptist Hospital Regional Cancer Ctr. Knoxville, Tennessee  37920
Vanderbilt Clinical Trials Office Nashville, Tennessee  37232-6307