Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	Pharmaceutical / Industry	EORTC-16007 COLLGARD-EORTC-16007, NCT00027677

Objectives

1. Determine the toxicity profile, maximum tolerated dose, and dose-limiting toxic effects of halofuginone hydrobromide in patients with progressive advanced solid tumors.
2. Establish a recommended dose of this drug for phase II study.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed advanced solid tumor that is not amenable to any clinical improvement by current standard treatments
  • No tumors of the upper digestive tract
• No clinical signs of CNS involvement

Prior/Concurrent Therapy:

Biologic therapy:

• At least 4 weeks since prior anticancer biologic therapy

Chemotherapy:

• At least 4 weeks since prior anticancer chemotherapy

Endocrine therapy:

• Prior anticancer hormonal therapy allowed

Radiotherapy:

• At least 6 weeks since prior radiotherapy
• No concurrent radiotherapy

Surgery:

• At least 2 weeks since prior surgery

Other:

• At least 4 weeks since other prior anticancer treatment
• No other concurrent anticancer agents or investigational therapy

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

  OR

• WHO 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• WBC at least 3,000/mm³
• Neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 10.0 g/dL

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST and ALT no greater than 2.5 times ULN
• No unstable hepatobiliary disease that would preclude study

Renal:

• Creatinine no greater than 1.5 times ULN
• No unstable renal disease that would preclude study

Cardiovascular:

• No unstable cardiovascular disease (e.g., stroke) that would preclude study

Pulmonary:

• No unstable pulmonary disease that would preclude study

Gastrointestinal:

• No digestive disease, including upper gastrointestinal tract, that would hamper absorption
• No evident/known lactose malabsorption

Other:

• No allergy to components of the study drug
• No uncontrolled infection
• No other unstable systemic disease that would preclude study
• No psychological, familial, sociological, or geographical condition that would preclude compliance
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study

Expected Enrollment

Approximately 7-40 patients will be accrued for this study.

Outline

This is a dose-escalation, multicenter study.

Patients receive oral halofuginone hydrobromide once daily on days 1 and 4-14 of course 1 and on days 1-14 of subsequent courses. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-3 patients receive escalating doses of halofuginone hydrobromide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 20% of patients experience acute dose-limiting toxicity. After the MTD is reached, 6-12 additional patients are treated at dose levels preceding the MTD until the recommended dose for phase II study is determined. The recommended dose for phase II study is defined as the dose preceding the MTD that allows a 90% dose intensity for 2 months with no greater than grade 2 toxicity in 80% of the patients.

Patients are followed every 8 weeks until disease progression or initiation of another treatment.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Maja De Jonge, MD, PhD, Study coordinator		Ph: 31-10-439-1911

Registry Information
Official Title		Phase I Study To Determine The Safety Of Halofuginone In Patients With A Solid Progressive Tumor
Trial Start Date		2001-08-28
Registered in ClinicalTrials.gov		NCT00027677
Date Submitted to PDQ		2001-10-11
Information Last Verified		2004-04-13

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