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Multi-Center, Phase Ib/IIa Safety and Preliminary Efficacy Study of Phenoxodiol (Intravenous) as a Chemo-Sensitizing Agent for Cisplatin and Paclitaxel in Epithelial Ovarian Cancer or Primary Peritoneal Cancer, Platinum- and/or Taxane-Refractory or Resistant


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

Multi-Center, Phase Ib/IIa Safety and Preliminary Efficacy Study of Phenoxodiol (Intravenous) as a Chemo-Sensitizing Agent for Cisplatin and Paclitaxel in Epithelial Ovarian Cancer or Primary Peritoneal Cancer, Platinum- and/or Taxane-Refractory or Resistant


OBJECTIVES:

Primary

- Compare the safety and tolerability of phenoxodiol combined with cisplatin or
paclitaxel in patients with recurrent late-stage ovarian epithelial, fallopian tube, or
primary peritoneal cancer that is refractory or resistant to platinum and/or taxane
drugs.

- Compare, preliminarily, tumor response in patients treated with these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1
of 2 treatment arms according to medical history.

- Arm I: Patients receive phenoxodiol IV over 10 minutes on days 1 and 2 and cisplatin IV
over 1 hour on day 2.

- Arm II: Patients receive phenoxodiol as in arm I and paclitaxel IV over 1 hour on day
2.

In both arms, treatment repeats every 6 weeks for up to 8 courses in the absence of disease
progression or unacceptable toxicity.

Quality of life is assessed at 12, 24, 36, and 48 weeks or at the end of study
participation.

Patients are followed at 6 and 12 months.

PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal
cancer

- Recurrent disease

- Received no more than 4 prior chemotherapy regimens for this malignancy

- Considered refractory or resistant to prior taxane (paclitaxel or docetaxel)
and/or platinum (cisplatin or carboplatin) therapy based on 1 of the following
criteria:

- Treatment-free interval < 6 months after platinum or paclitaxel

- Disease progression during platinum- or paclitaxel-based therapy

- Measurable or evaluable disease

- Measurable disease is defined as at least 1 unidimensionally measurable lesion ≥
20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

- Evaluable disease is defined as doubling of CA 125 blood levels within the past
6 months AND CA 125 level ≥ 2 times upper limit of normal (ULN) within the past
week

- No active CNS metastases

- Patients with known CNS metastases must have received prior radiotherapy or
CNS-directed chemotherapy AND have ≥ 4 weeks of stable disease

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- Karnofsky 60-100%

Life expectancy

- At least 3 months

Hematopoietic

- Neutrophil count > 1,500/mm^3

- Platelet count > 100,000/mm^3

- WBC > 3,000/mm^3

- Hematocrit ≥ 28% (transfusion or growth factors allowed)

- Hemoglobin > 8.0 g/dL (transfusion or growth factors allowed)

Hepatic

- Bilirubin ≤ 1.5 times ULN

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

Renal

- Creatinine ≤ 1.5 times ULN

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infection requiring antibiotics

- No neuropathy (sensory or motor) > grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent immunotherapy

Chemotherapy

- See Disease Characteristics

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent hormonal therapy for the malignancy

Radiotherapy

- See Disease Characteristics

- No prior whole abdominal radiotherapy

- Concurrent localized radiotherapy allowed for control of local complications not
indicative of general disease progression

Surgery

- Not specified

Other

- Recovered from prior antineoplastic therapy

- More than 4 weeks since prior standard therapy for malignant tumor

- More than 6 months since prior investigational anticancer drugs

- No other concurrent investigational drugs

- No concurrent drugs significantly metabolized by the cytochrome P450 enzymes CYP2C8,
CYP2C9, CYP2C19, and CYP3A4/B1C

- No concurrent amifostine or other protective agents

- No concurrent grapefruit juice

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability

Outcome Time Frame:

Average 6 mo

Safety Issue:

Yes

Principal Investigator

Warren Lancaster

Investigator Role:

Study Chair

Investigator Affiliation:

Novogen

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000389129

NCT ID:

NCT00091377

Start Date:

August 2004

Completion Date:

March 2008

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Yale Comprehensive Cancer Center at Yale University School of MedicineNew Haven, Connecticut  06520-8064