Trial | NCT00022295  Report issue

Title

Phenoxodiol in Treating Patients With Refractory Solid Tumors
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    36
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.
OBJECTIVES:

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.
Study Started
Aug 31
2001
Study Completion
Oct 31
2007
Last Update
Mar 26
2013
Estimate

Drug idronoxil

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

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 60-100%

Life expectancy:

At least 3 months

Hematopoietic:

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)

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

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
No Results Posted