Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00006230

Collaborator

(none)

Enrollment

Locations

3.9

Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Drug: rubitecan	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

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

Study Start Date :

May 1, 2000

Actual Primary Completion Date :

Apr 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Institut Jules Bordet	Brussels		Belgium	B-1000
2	Centre Jean Perrin	Clermont-Ferrand		France	63011
3	Centre de Lutte Contre le Cancer, Georges-Francois Leclerc	Dijon		France	21079
4	CHU de la Timone	Marseille		France	13385
5	CRLCC Nantes - Atlantique	Nantes-Saint Herblain		France	44805
6	Centre Eugene Marquis	Rennes		France	35042
7	Rabin Medical Center - Beilinson Campus	Petah-Tikva		Israel	49100
8	Azienda Ospedaliera di Padova	Padova (Padua)		Italy	35128
9	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
10	Ospedale San Giovanni	Bellinzona		Switzerland	6500
11	Clinique De Genolier	Genolier		Switzerland	Ch-1272
12	Newcastle General Hospital	Newcastle Upon Tyne	England	United Kingdom	NE4 6BE
13	Western General Hospital	Edinburgh	Scotland	United Kingdom	EH4 2XU