Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006230
• Other study ID #: EORTC-16996O
• Secondary ID: EORTC-16996O
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2000
• Last updated: September 20, 2012
• Start date: May 2000

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• rubitecan

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussels
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre de Lutte Contre le Cancer, Georges-Francois Leclerc	Dijon
France	CHU de la Timone	Marseille
France	CRLCC Nantes - Atlantique	Nantes-Saint Herblain
France	Centre Eugene Marquis	Rennes
Israel	Rabin Medical Center - Beilinson Campus	Petah-Tikva
Italy	Azienda Ospedaliera di Padova	Padova (Padua)
Spain	Hospital Universitario 12 de Octubre	Madrid
Switzerland	Ospedale San Giovanni	Bellinzona
Switzerland	Clinique De Genolier	Genolier
United Kingdom	Western General Hospital	Edinburgh	Scotland
United Kingdom	Newcastle General Hospital	Newcastle Upon Tyne	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  France,  Israel,  Italy,  Spain,  Switzerland,  United Kingdom,