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CHS 828 in Treating Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003979
Recruitment Status : Withdrawn
First Posted : January 27, 2003
Last Update Posted : July 11, 2012
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.


Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: CHS 828 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
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 Start Date : April 1999




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003979


Locations
Show Show 28 study locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
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Study Chair: Thomas Cerny, MD Cantonal Hospital of St. Gallen

Publications of Results:
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00003979    
Other Study ID Numbers: EORTC-16985
EORTC-16985
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: July 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Neoplasms