Clinical trial NCT00003979: CHS 828 in Treating Patients With Solid Tumors
Official title: Phase I and Pharmacokinetics Study to Determine the Safety of CHS 828 in Patients With a Solid Tumor on a Single Oral Dose Repeated Every 3 Weeks
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2003-01-27
Enrollment: 0
Sex: ALL
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 I trial to study the effectiveness of CHS 828 in treating patients who have solid tumors.

Detailed description: OBJECTIVES:

* Determine the maximum tolerated dose of oral CHS 828 in patients with solid tumors.
* Determine the qualitative and quantitative toxic effects of this regimen in these patients.
* Determine a safe dose of this regimen for phase II evaluation.
* Determine the pharmacokinetic profile of this regimen in these patients.
* Determine any antitumor activity in these patients.

OUTLINE: Patients receive oral CHS 828 every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of CHS 828 until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity.

Patients are followed for up to 4 weeks.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12 months.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed solid tumor not amenable to standard therapy
* No symptomatic brain or leptomeningeal involvement

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* WHO 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* WBC at least 4,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin less than 1.5 mg/dL
* Other liver function tests no greater than 2 times upper limit of normal (unless related to liver metastases)

Renal:

* Creatinine no greater than 1.4 mg/dL

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No active bacterial infection
* No other nonmalignant disease
* No alcoholism, drug addiction, or psychiatric disorders
* Able to take oral medication

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior immunotherapy

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas)
* No other concurrent chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 4 weeks since prior radiotherapy (6 weeks since extensive radiotherapy)
* No concurrent radiotherapy (except palliative radiotherapy)

Surgery:

* Not specified

Other:

* No other concurrent investigational drugs
* No other concurrent antitumor drugs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Innsbruck Universitaetsklinik
city: Vienna
country: Austria
facility: Kaiser Franz Josef Hospital
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Ludwig Institute for Cancer Research
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Leuven
country: Belgium
facility: U.Z. Gasthuisberg
city: Copenhagen
country: Denmark
facility: Herlev Hospital - University Hospital of Copenhagen
city: Bordeaux
country: France
facility: Institut Bergonie
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Lyon
country: France
facility: Centre Leon Berard
city: Nantes-Saint Herblain
country: France
facility: CRLCC Nantes - Atlantique
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Essen
country: Germany
facility: Universitaetsklinik und Strahlenklinik - Essen
city: Nuremberg
country: Germany
facility: Klinikum Nuernberg - Klinikum Nord
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoekhuis
city: Groningen
country: Netherlands
facility: Academisch Ziekenhuis Groningen
city: Nijmegen
country: Netherlands
facility: University Medical Center Nijmegen
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Oslo
country: Norway
facility: Norwegian Radium Hospital
city: Basel
country: Switzerland
facility: University Hospital
city: Bern
country: Switzerland
facility: Inselspital, Bern
city: St. Gallen
country: Switzerland
facility: Kantonsspital - St. Gallen
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle General Hospital
state: England
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
state: Scotland
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: Scotland
city: Glasgow
country: United Kingdom
facility: C.R.C. Beatson Laboratories
state: Scotland
Study officials:
affiliation: Cantonal Hospital of St. Gallen
name: Thomas Cerny, MD
role: STUDY_CHAIR
References:
citation: Ravaud A, Cerny T, Terret C, Wanders J, Bui BN, Hess D, Droz JP, Fumoleau P, Twelves C. Phase I study and pharmacokinetic of CHS-828, a guanidino-containing compound, administered orally as a single dose every 3 weeks in solid tumours: an ECSG/EORTC study. Eur J Cancer. 2005 Mar;41(5):702-7. doi: 10.1016/j.ejca.2004.12.023.