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

Alternate Title

Phenoxodiol in Treating Patients With Refractory Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over Pharmaceutical / Industry NOVOGEN-NV06-0024 CCF-4269, NCI-V01-1663, NCT00022295

Objectives

1. Determine the maximum tolerated dose of phenoxodiol in patients with refractory solid tumors.
2. Determine the steady-state pharmacokinetics of this drug in these patients.
3. Determine the tumor response in patients treated with this drug.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed solid tumor
  • Refractory to standard therapy

    OR

  • No standard therapy exists



• No breast cancer



• No active CNS metastases
  • Known CNS metastases must be previously treated with radiotherapy or surgery and stable for at least 4 weeks prior to study

Prior/Concurrent Therapy:

Biologic therapy:

• No concurrent systemic anticancer immunotherapy

Chemotherapy:

• No concurrent systemic anticancer chemotherapy

Endocrine therapy:

• No concurrent systemic anticancer hormonal therapy except luteinizing hormone-releasing hormone agonists or antagonists

Radiotherapy:

• See Disease Characteristics
• Concurrent localized radiotherapy for control of local disease complications allowed

Surgery:

• See Disease Characteristics

Other:

• Recovered from prior antineoplastic therapy
• At least 4 weeks since prior investigational agents
• No other concurrent investigational drugs

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 3 months

Hematopoietic:

• Platelet count greater than 100,000/mm³
• WBC greater than 3,000/mm³
• Neutrophil count greater than 1,500/mm³
• Hemoglobin greater than 10 g/dL (9 g/dL for women)

Hepatic:

• Bilirubin less than 1.2 mg/dL
• Transaminases no greater than 3 times upper limit of normal

Renal:

• Creatinine no greater than 1.4 mg/dL

Other:

• No active infection
• No contraindication to the insertion of a vascular access device
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

Approximately 18-36 patients will be accrued for this study.

Outline

This is a multicenter, dose-escalation study.

Patients receive phenoxodiol IV continuously over days 1-7. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of phenoxodiol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 4 weeks.

Trial Contact Information

Trial Lead Organizations

Novogen, Incorporated

Graham Kelly, PhD, Protocol chair		Ph: 612 9878 088

Registry Information
Official Title		Phase IB Study of Phenoxodiol Given by Constant Intravenous Infusion in Patients with Solid Neoplasms (With the Exception of Breast Cancer) Whose Tumors are Refractory to Standard Therapy
Trial Start Date		2001-08-20
Registered in ClinicalTrials.gov		NCT00022295
Date Submitted to PDQ		2001-06-11
Information Last Verified		2007-03-27

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