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Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Treating Patients With Recurrent Late-Stage Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
This study is ongoing, but not recruiting participants.
First Received: September 7, 2004   Last Updated: July 23, 2008   History of Changes
Sponsored by: Marshall Edwards, Inc
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00091377
  Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Phenoxodiol may help cisplatin and paclitaxel kill more tumor cells by making tumor cells more sensitive to the drugs.

PURPOSE: This randomized phase I/II trial is studying the side effects of phenoxodiol when given together with either cisplatin or paclitaxel and to see how well they work in treating patients with recurrent late-stage ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that has not responded to treatment with drugs such as paclitaxel, docetaxel, cisplatin, or carboplatin.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: cisplatin
Drug: paclitaxel
Drug: phenoxodiol
Phase I
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Cisplatin Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Multi-Center, Phase Ib/IIa Safety and Preliminary Efficacy Study of Phenoxodiol (Intravenous Dosage Form) as a Chemo-Sensitizing Agent for Cisplatin and Paclitaxel in Epithelial Ovarian Cancer or Primary Peritoneal Cancer That is Platinum- and/or Taxane-Refractory or Resistant

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

Primary Outcome Measures:
  • Safety and tolerability [ Designated as safety issue: Yes ]
  • Efficacy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surrogate marker of tumor response in terms of plasma protein tNOX [ Designated as safety issue: No ]

Study Start Date: August 2004
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091377

Locations
United States, Connecticut
Yale Comprehensive Cancer Center at Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8028
Australia, Victoria
Royal Women's Hospital
Carlton, Victoria, Australia, 3053
Sponsors and Collaborators
Marshall Edwards, Inc
Investigators
Investigator: Warren Lancaster Novogen
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000389129, NOVOGEN-NV06-037, YALE-HIC-26423
Study First Received: September 7, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00091377     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Study placed in the following topic categories:
Fallopian Tube Cancer
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Cisplatin
Peritoneal Diseases
Ovarian Cancer
Taxane
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Antimitotic Agents
Abdominal Neoplasms
Ovarian Epithelial Cancer
Recurrence
Fallopian Tube Neoplasms
Fallopian Tube Diseases
Digestive System Diseases
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Gastrointestinal Neoplasms
Peritoneal Neoplasms
Endocrinopathy
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Cisplatin
Therapeutic Uses
Peritoneal Diseases
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Antimitotic Agents
Abdominal Neoplasms
Fallopian Tube Neoplasms
Pharmacologic Actions
Adnexal Diseases
Fallopian Tube Diseases
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Peritoneal Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 06, 2009