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Home > "N" Clinical Trials Conditions > Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer  Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer
Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer
For Condition: stage 3 ovarian epithelial cancer,recurrent ovarian epithelial cancer,stage 4 ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): EORTC New Drug Development Group ,
Synopsis: 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 ovarian cancer.
Details: OBJECTIVES: - Determine the objective response rate and duration of response in patients with advanced ovarian cancer treated with nitrocamptothecin. - Determine the probability of objective response as expressed by the response rate in patients treated with this regimen. - Determine the toxicity of this regimen in these patients. 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 PR or CR. Patients are followed every 6 weeks until disease progression or the initiation of another antitumor therapy. PROJECTED ACCRUAL: A total of 28-50 patients (14-25 per stratum) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven metastatic or unresectable locally advanced progressive ovarian cancer that has failed first line platinum and taxane based regimen - Refractory disease defined by a relapse within 1 year after completion of first line therapy - Sensitive disease defined by a relapse greater than 1 year after completion of first line therapy - Minimum of 1 target lesion that can be accurately measured in at least 1 dimension - At least 20 mm by conventional techniques OR - At least 10 mm by spiral CT scan - No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - Neutrophil count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase, SGOT, and SGPT no greater than 2.5 times ULN (no greater than 5 times ULN if hepatic metastases present) Renal: - Creatinine no greater than 1.7 mg/dL Cardiovascular: - No ischemic heart disease within the past 6 months - Normal 12 lead electrocardiogram Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No unstable systemic disease or active uncontrolled infections - No other prior or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer or cone biopsied carcinoma of the cervix - No psychological, familial, sociological, or geographical condition that would preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent filgrastim (G-CSF) with nitrocamptothecin Chemotherapy: - See Disease Characteristics - Greater than 4 weeks since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Greater than 4 weeks since prior radiotherapy Surgery: - Greater than 2 weeks since prior major surgery Other: - No other concurrent anticancer agents - No other concurrent investigational therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PierreFumoleau, Study Chair, CRLCC Nantes - Atlantique
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Hospital Universitario 12 de Octubre
Madrid, , 28041
Spain
Centre Eugene Marquis
Rennes, , 35042
France
Azienda Ospedaliera di Padova
Padova (Padua), , 35128
Italy
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , 44805
France
Institut Jules Bordet
Brussels, , B-1000
Belgium
Ospedale San Giovanni
Bellinzona, , 6500
Switzerland
Western General Hospital
Edinburgh, Scotland, EH4 2XU
United Kingdom
Centre Jean Perrin
Clermont-Ferrand, , 63011
France
Rabin Medical Center - Beilinson Campus
Petah-Tikva, , 49100
Israel
CHU de la Timone
Marseille, , 13385
France
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Dijon, , 21079
France
Clinique De Genolier
Genolier, , Ch-1272
Switzerland
Additional Information:
Study ID Numbers: CDR0000068154; EORTC-16996O
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006230
Other Stage 3 Ovarian Epithelial Cancer Studies:
1. Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer
2. Quality-of-Life Assessment in Patients With Ovarian Cancer
3. Carboplatin With or Without Thalidomide in Treating Patients With Ovarian Epithelial Cancer
4. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
5. Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission
Related Studies:
Other stage 3 ovarian epithelial cancer Clinical Trials
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Other Brussels Clinical Trials
Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer
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