Status:
COMPLETED
Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Lead Sponsor:
MEI Pharma, Inc.
Conditions:
Fallopian Tube Cancer
Ovarian Cancer
Eligibility:
FEMALE
18-120 years
Phase:
PHASE1
PHASE2
Brief 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 paclit...
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 pe...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00091377
Start Date
August 1 2004
End Date
March 1 2008
Last Update
July 14 2016
Active Locations (2)
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1
Yale Comprehensive Cancer Center at Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8028
2
Royal Women's Hospital
Carlton, Victoria, Australia, 3053