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Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
cisplatin
paclitaxel
phenoxodiol
Sponsored by
MEI Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Yale Comprehensive Cancer Center at Yale University School of Medicine
  • Royal Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm Description

Phenoxodiol IV 3 mg/kg combined with cisplatin 40 mg/m2 on Day 2 6 week cycles

Phenoxodiol IV 3 mg/kg combined with paclitaxel 80 mg/m2 on Day 2 6 week cycles

Outcomes

Primary Outcome Measures

Safety and tolerability
Efficacy

Secondary Outcome Measures

Surrogate marker of tumor response in terms of plasma protein tNOX

Full Information

First Posted
September 7, 2004
Last Updated
July 13, 2016
Sponsor
MEI Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00091377
Brief Title
Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MEI Pharma, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Phenoxodiol IV 3 mg/kg combined with cisplatin 40 mg/m2 on Day 2 6 week cycles
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Phenoxodiol IV 3 mg/kg combined with paclitaxel 80 mg/m2 on Day 2 6 week cycles
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
IV 40 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
IV 80 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.
Intervention Type
Drug
Intervention Name(s)
phenoxodiol
Intervention Description
IV 3 mg/kg
Primary Outcome Measure Information:
Title
Safety and tolerability
Time Frame
Average 6 mo
Title
Efficacy
Time Frame
Average 6 months
Secondary Outcome Measure Information:
Title
Surrogate marker of tumor response in terms of plasma protein tNOX
Time Frame
Average 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren Lancaster
Organizational Affiliation
Kazia Therapeutics Limited
Official's Role
Study Chair
Facility Information:
Facility Name
Yale Comprehensive Cancer Center at Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8028
Country
United States
Facility Name
Royal Women's Hospital
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
21412168
Citation
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 primary peritoneal cancers. Int J Gynecol Cancer. 2011 May;21(4):633-9. doi: 10.1097/IGC.0b013e3182126f05.
Results Reference
result

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Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

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