Clinical trial NCT00006230: Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2003-01-27
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
city: Marseille
country: France
facility: CHU de la Timone
city: Nantes-Saint Herblain
country: France
facility: CRLCC Nantes - Atlantique
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center - Beilinson Campus
city: Padova (Padua)
country: Italy
facility: Azienda Ospedaliera di Padova
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Bellinzona
country: Switzerland
facility: Ospedale San Giovanni
city: Genolier
country: Switzerland
facility: Clinique De Genolier
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle General Hospital
state: England
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: Scotland
Study officials:
affiliation: Centre Georges Francois Leclerc
name: Pierre Fumoleau, MD, PhD
role: STUDY_CHAIR
References: