Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: rubitecan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 Ovarian Cancer |
| Enrollment: | 51 |
| Study Start Date: | May 2000 |
| Primary Completion Date: | April 2003 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Belgium | |
| Institut Jules Bordet | |
| Brussels, Belgium, B-1000 | |
| France | |
| Centre Jean Perrin | |
| Clermont-Ferrand, France, 63011 | |
| Centre de Lutte Contre le Cancer, Georges-Francois Leclerc | |
| Dijon, France, 21079 | |
| CHU de la Timone | |
| Marseille, France, 13385 | |
| CRLCC Nantes - Atlantique | |
| Nantes-Saint Herblain, France, 44805 | |
| Centre Eugene Marquis | |
| Rennes, France, 35042 | |
| Israel | |
| Rabin Medical Center - Beilinson Campus | |
| Petah-Tikva, Israel, 49100 | |
| Italy | |
| Azienda Ospedaliera di Padova | |
| Padova (Padua), Italy, 35128 | |
| Spain | |
| Hospital Universitario 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Switzerland | |
| Ospedale San Giovanni | |
| Bellinzona, Switzerland, 6500 | |
| Clinique De Genolier | |
| Genolier, Switzerland, Ch-1272 | |
| United Kingdom | |
| Newcastle General Hospital | |
| Newcastle Upon Tyne, England, United Kingdom, NE4 6BE | |
| Western General Hospital | |
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |
| Study Chair: | Pierre Fumoleau, MD, PhD | Centre de Lutte Contre le Cancer Georges-Francois Leclerc |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00006230 History of Changes |
| Other Study ID Numbers: | EORTC-16996O, EORTC-16996O |
| Study First Received: | September 11, 2000 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female |
Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders 9-nitrocamptothecin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013