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
18 Years
N/A
Female
Ovarian Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Pierre Fumoleau, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Authority:
United States: Federal Government
Study ID:
EORTC-16996O
NCT ID:
NCT00006230
Start Date:
May 2000
Completion Date:
Related Keywords:
- Ovarian Cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- recurrent ovarian epithelial cancer
- Ovarian Neoplasms
Name | Location |
|---|
