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
cisplatin
+ phenoxodiol
+ paclitaxel
Carcinoma, Ovarian Epithelial+18
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: August 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.65 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Yale Comprehensive Cancer Center at Yale University School of Medicine
New Haven, United StatesOpen Yale Comprehensive Cancer Center at Yale University School of Medicine in Google MapsRoyal Women's Hospital
Carlton, Australia