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Phenoxodiol in Treating Patients With Refractory Solid Tumors

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: August 10, 2001
Last updated: March 25, 2013
Last verified: March 2007

RATIONALE: Phenoxodiol may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase I trial to study the effectiveness of phenoxodiol in treating patients who have refractory solid tumors.

Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: idronoxil Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 36
Study Start Date: August 2001
Study Completion Date: October 2007
Detailed Description:


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

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.

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


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


  • 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



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 3 months


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


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


  • Creatinine no greater than 1.4 mg/dL


  • 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


Biologic therapy:

  • No concurrent systemic anticancer immunotherapy


  • No concurrent systemic anticancer chemotherapy

Endocrine therapy:

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


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


  • See Disease Characteristics


  • Recovered from prior antineoplastic therapy
  • At least 4 weeks since prior investigational agents
  • No other concurrent investigational drugs
  Contacts and Locations
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Please refer to this study by its identifier: NCT00022295

United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Novogen Ltd
Study Chair: Graham Kelly, PhD MEI Pharma, Inc.
  More Information Identifier: NCT00022295     History of Changes
Other Study ID Numbers: CDR0000068802
Study First Received: August 10, 2001
Last Updated: March 25, 2013

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific processed this record on June 26, 2017