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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

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

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