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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00091377
Other study ID # CDR0000389129
Secondary ID NOVOGEN-NV06-037
Status Completed
Phase Phase 1/Phase 2
First received September 7, 2004
Last updated July 13, 2016
Start date August 2004
Est. completion date March 2008

Study information

Verified date July 2016
Source MEI Pharma, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date March 2008
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 120 Years
Eligibility 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

Study Design

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


Intervention

Drug:
cisplatin
IV 40 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.
paclitaxel
IV 80 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.
phenoxodiol
IV 3 mg/kg

Locations

Country Name City State
Australia Royal Women's Hospital Carlton Victoria
United States Yale Comprehensive Cancer Center at Yale University School of Medicine New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
MEI Pharma, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

References & Publications (1)

Kelly MG, Mor G, Husband A, O'Malley DM, Baker L, Azodi M, Schwartz PE, Rutherford TJ. Phase II evaluation of phenoxodiol in combination with cisplatin or paclitaxel in women with platinum/taxane-refractory/resistant epithelial ovarian, fallopian tube, or — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability Average 6 mo Yes
Primary Efficacy Average 6 months No
Secondary Surrogate marker of tumor response in terms of plasma protein tNOX Average 6 months No
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