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Fallopian Tube CancerPhase 1/2NCT00091377

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

A Phase 1/2 study testing cisplatin, paclitaxel and phenoxodiol in people with Fallopian Tube Cancer and Ovarian Cancer, run by MEI Pharma, Inc. at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
What is being tested?
cisplatin, paclitaxel and phenoxodiol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
2 sitesin 2 countries
Study dates
Aug 2004to Mar 2008
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Yale Comprehensive Cancer Center at Yale University School of Medicine

    New Haven, Connecticut, 06520-8028

Other trials in United States

Australia1 site

  • Royal Women's Hospital

    Carlton, Victoria, 3053

Other trials in Australia

About this study

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

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.

Read the 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.

Being tested
cisplatin, paclitaxel, phenoxodiol
Keywords
recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cisplatinDrug

    IV 40 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.

  • paclitaxelDrug

    IV 80 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.

  • phenoxodiolDrug

    IV 3 mg/kg

Study groups in NCT00091377
Study groupRoleWhat they receive
Arm AExperimentalPhenoxodiol IV 3 mg/kg combined with cisplatin 40 mg/m2 on Day 2 6 week cycles
Receives: Drug: cisplatin; Drug: phenoxodiol
Arm BExperimentalPhenoxodiol IV 3 mg/kg combined with paclitaxel 80 mg/m2 on Day 2 6 week cycles
Receives: Drug: paclitaxel; Drug: phenoxodiol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability

    Measured: Average 6 mo

  2. Efficacy

    Measured: Average 6 months

Secondary outcomes (1)

  1. Surrogate marker of tumor response in terms of plasma protein tNOX

    Measured: Average 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2004 (estimated)
  2. Study startAug 2004
  3. Primary completionDec 2007
  4. Study completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00091377
Sponsor's protocol ID
CDR0000389129
Other IDs
NOVOGEN-NV06-037, YALE-HIC-26423
Status last verified
Jul 2016
First submitted
7 Sep 2004
Last updated
14 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21412168

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing cisplatin, paclitaxel and phenoxodiol in people with Fallopian Tube Cancer and Ovarian Cancer, run by MEI Pharma, Inc. at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability (time frame: Average 6 mo). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00091377, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.

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