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Sponsored by: |
European Organization for Research and Treatment of Cancer |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006082 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced small cell lung cancer.
Condition | Intervention | Phase |
Lung Cancer |
Drug: rubitecan |
Phase II |
MedlinePlus related topics: | Cancer Lung Cancer |
ChemIDplus related topics: | Camptothecin Rubitecan |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On - 2 Days Off" Oral Treatment in Advanced Small Cell Lung Cancer |
Study Start Date: | May 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to disease status (sensitive vs refractory).
Patients receive oral nitrocamptothecin daily for 5 consecutive days each week for 3 weeks. Treatment continues every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD) receive up to 4 additional courses past SD. Patients who achieve partial response (PR) or complete response (CR) receive a minimum of 2 additional courses past CR or PR.
Patients are followed every 6 weeks until disease progression or initiation of another antitumor treatment.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for the sensitive disease stratum and a total of 19-24 patients will be accrued for the refractory disease stratum
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven advanced (extensive stage) small cell lung cancer with progressive or recurrent disease after 1 first line chemotherapy regimen
Minimum of 1 target lesion that can be accurately measured in at least 1 dimension
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
France | |||||
CRLCC Nantes - Atlantique | |||||
Nantes-Saint Herblain, France, 44805 |
European Organization for Research and Treatment of Cancer |
Study Chair: | Pierre Fumoleau, MD, PhD | Centre de Lutte Contre le Cancer Georges-Francois Leclerc |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000068074, EORTC-16996SL |
First Received: | August 3, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006082 |
Health Authority: | United States: Federal Government |
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