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A Randomized Placebo-Controlled Phase Ib/IIa Safety, Tolerability and Efficacy Study of Oral Phenoxodiol in Combination With Docetaxel Versus Docetaxel Alone in Patients With Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

A Randomized Placebo-Controlled Phase Ib/IIa Safety, Tolerability and Efficacy Study of Oral Phenoxodiol in Combination With Docetaxel Versus Docetaxel Alone in Patients With Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer


OBJECTIVES:

Primary

- Determine the safety and tolerability of combination therapy comprising phenoxodiol and
docetaxel in patients with recurrent or persistent advanced ovarian epithelial,
fallopian tube, or primary peritoneal cavity cancer.

Secondary

- Determine the effect of phenoxodiol on the toxicity of docetaxel using a weekly
treatment regimen.

- Determine if combination therapy comprising phenoxodiol and docetaxel is more
efficacious than docetaxel therapy alone.

- Determine if combination therapy comprising phenoxodiol and docetaxel affects blood
levels of either drug.

- Determine phenotypic differences in the tumor cells of "responders" and
"non-responders."

OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15 and oral placebo
three times daily on days 1-21.

- Arm II: Patients receive oral phenoxodiol three times daily on days 1-21 and docetaxel
as in arm I.

Treatment in both arms repeats every 4 weeks for up to 12 courses in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed monthly for 6 months, every 3
months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of 1 of the following:

- Ovarian epithelial cancer

- Fallopian tube cancer

- Primary peritoneal cavity cancer

- Recurrent advanced disease

- Eligible for second-line to fifth-line chemotherapy

- Received platinum and taxane combination chemotherapy as first-line treatment
with disease recurrence > 6 months after conclusion of therapy

- No demonstrated refractoriness or resistance to weekly docetaxel

- Meets 1 of the following criteria:

- Doubling of blood levels of CA125 in the past 6 months and CA125 levels ≥ 2
times upper limit of normal (ULN)

- Measurable disease defined as ≥ 1 lesion ≥ 20 mm by conventional techniques or ≥
10 mm by spiral CT scan

- No active CNS metastases

- Prior CNS metastases allowed provided they were treated with radiation therapy
and disease has been stable for 4 weeks

PATIENT CHARACTERISTICS:

- Karnofsky performance score ≥ 60%

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after
completion of study treatment

- Life expectancy ≥ 3 months

- Creatinine ≤ 1.5 mg/dL

- Transaminases ≤ 3 times upper limit of normal (ULN)

- Bilirubin normal

- Platelet count > 100,000/mm^3

- WBC > 3,000/mm^3

- Neutrophil count > 1,500/mm^3

- Hemoglobin ≥ 8.0 g/dL

- Peripheral neuropathy ≤ grade 1

- Relative proportions of AST, ALT, and alkaline phosphatase according 1 to the
following criteria:

- Alkaline phosphatase (AP) normal AND AST/ALT ≤ 5 times ULN

- AP ≤ 2.5 times ULN AND AST/ALT ≤ 1.5 times ULN

- AP ≤ 5 times ULN AND AST/ALT normal

- No active infection

- No concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled
diabetes, hypertension, ischemic heart disease, or congestive heart failure)

- No history of chronic active hepatitis or cirrhosis

- No history of severe hypersensitivity to docetaxel or other drugs formulated with
polysorbate 80

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No investigational agents within 4 weeks prior to study entry

- Recovered from prior antineoplastic therapy

- No other concurrent investigational drugs

- No other concurrent chemotherapy, radiotherapy, immunotherapy, or hormonal antitumor
therapy

- Concurrent localized radiation therapy allowed for control of local disease
complications (e.g., bone metastases) that do not represent a general
progression of the disease status

- No concurrent grapefruit or grapefruit juice

- No concurrent amifostine

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Survival (progression-free/recurrence-free interval and overall survival)

Safety Issue:

No

Principal Investigator

Thomas J. Rutherford, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University

Authority:

Unspecified

Study ID:

CDR0000462103

NCT ID:

NCT00303888

Start Date:

April 2006

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • peritoneal cavity cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Yale Cancer CenterNew Haven, Connecticut  06520-8028