![]() |
|
![]() |
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00084487 |
RATIONALE: Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studing how well rebeccamycin analog works as second-line therapy in treating patients with limited-stage or extensive-stage small cell lung cancer that has relapsed after previous first-line chemotherapy.
Condition | Intervention | Phase |
Lung Cancer |
Drug: becatecarin |
Phase II |
MedlinePlus related topics: | Cancer Lung Cancer |
ChemIDplus related topics: | BMS 181176 |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of XL119 (Rebeccamycin Analogue) in Relapsed "Sensitive" Small Cell Lung Cancer |
Estimated Enrollment: | 39 |
Study Start Date: | April 2004 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed annually.
PROJECTED ACCRUAL: A total of 20-39 patients will be accrued for this study within 15 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of small cell lung cancer (SCLC)
Brain metastasis allowed provided the following criteria are met:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Ohio | |||||
Case Comprehensive Cancer Center | |||||
Cleveland, Ohio, United States, 44106-5065 | |||||
Cleveland Clinic Taussig Cancer Center | |||||
Cleveland, Ohio, United States, 44195 | |||||
MetroHealth Cancer Care Center at MetroHealth Medical Center | |||||
Cleveland, Ohio, United States |
Case Comprehensive Cancer Center |
National Cancer Institute (NCI) |
Principal Investigator: | Afshin Dowlati, MD | Case Comprehensive Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
![]()   |
Study ID Numbers: | CDR0000365315, CASE-CWRU-1503, NCI-1990, CASE-1503 |
First Received: | June 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00084487 |
Health Authority: | United States: Food and Drug Administration |
|
|
|
|
![]() |