AzTrials
AzTrials

Fallopian Tube CancerPhase 1NCT00303888

Docetaxel With or Without Phenoxodiol in Treating Patients With Recurrent Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer

A Phase 1 study testing docetaxel and idronoxil in people with Fallopian Tube Cancer and Ovarian Cancer, run by Yale University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Phenoxodiol may help docetaxel work better by making tumor cells more sensitive to the drug. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
What is being tested?
docetaxel and idronoxil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
1 siteUnited States
Study dates
May 2006to Oct 2009
Phase
Phase 1
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 diagnosis of 1 of the following:
  • Ovarian epithelial cancer
  • Fallopian tube cancer
  • Primary peritoneal cavity cancer
  • Recurrent advanced disease
  • Eligible for second-line to fifth-line chemotherapy
  • Received platinum and taxane combination chemotherapy as first-line treatment with disease recurrence > 6 months after conclusion of therapy
  • No demonstrated refractoriness or resistance to weekly docetaxel
  • Meets 1 of the following criteria:
  • Doubling of blood levels of CA125 in the past 6 months and CA125 levels ≥ 2 times upper limit of normal (ULN)
  • Measurable disease defined as ≥ 1 lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
  • No active CNS metastases
  • Prior CNS metastases allowed provided they were treated with radiation therapy and disease has been stable for 4 weeks

PATIENT CHARACTERISTICS:

  • Karnofsky performance score ≥ 60%
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • Life expectancy ≥ 3 months
  • Creatinine ≤ 1.5 mg/dL
  • Transaminases ≤ 3 times upper limit of normal (ULN)
  • Bilirubin normal
  • Platelet count > 100,000/mm^3
  • WBC > 3,000/mm^3
  • Neutrophil count > 1,500/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Peripheral neuropathy ≤ grade 1
  • Relative proportions of AST, ALT, and alkaline phosphatase according 1 to the following criteria:
  • Alkaline phosphatase (AP) normal AND AST/ALT ≤ 5 times ULN
  • AP ≤ 2.5 times ULN AND AST/ALT ≤ 1.5 times ULN
  • AP ≤ 5 times ULN AND AST/ALT normal
  • No active infection
  • No concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, hypertension, ischemic heart disease, or congestive heart failure)
  • No history of chronic active hepatitis or cirrhosis
  • No history of severe hypersensitivity to docetaxel or other drugs formulated with polysorbate 80

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No investigational agents within 4 weeks prior to study entry
  • Recovered from prior antineoplastic therapy
  • No other concurrent investigational drugs
  • No other concurrent chemotherapy, radiotherapy, immunotherapy, or hormonal antitumor therapy
  • Concurrent localized radiation therapy allowed for control of local disease complications (e.g., bone metastases) that do not represent a general progression of the disease status
  • No concurrent grapefruit or grapefruit juice
  • No concurrent amifostine

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale Cancer Center

    New Haven, Connecticut, 06520-8028

Other trials in United States

About this study

Official title: A Randomized Placebo-Controlled Phase Ib/IIa Safety, Tolerability and Efficacy Study of Oral Phenoxodiol in Combination With Docetaxel Versus Docetaxel Alone in Patients With Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Phenoxodiol may help docetaxel work better by making tumor cells more sensitive to the drug.

PURPOSE: This randomized phase I/II trial is studying the side effects of docetaxel when given together with either phenoxodiol or placebo and to see how well it works in treating patients with recurrent advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the safety and tolerability of combination therapy comprising phenoxodiol and docetaxel in patients with recurrent or persistent advanced ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.

Secondary

  • Determine the effect of phenoxodiol on the toxicity of docetaxel using a weekly treatment regimen.
  • Determine if combination therapy comprising phenoxodiol and docetaxel is more efficacious than docetaxel therapy alone.
  • Determine if combination therapy comprising phenoxodiol and docetaxel affects blood levels of either drug.
  • Determine phenotypic differences in the tumor cells of "responders" and "non-responders."

OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15 and oral placebo three times daily on days 1-21.
  • Arm II: Patients receive oral phenoxodiol three times daily on days 1-21 and docetaxel as in arm I.

Treatment in both arms repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed monthly for 6 months, every 3 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

3/31/2017 NOTE

This study was terminated 10/2009 due to lack of enrollment. The study never progressed to Phase 2.

Being tested
docetaxel, idronoxil, placebo
Keywords
recurrent ovarian epithelial cancer, stage IV ovarian epithelial cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, recurrent primary peritoneal cavity cancer, stage IIIA primary peritoneal cavity cancer, stage IIIB primary peritoneal cavity cancer, stage IIIC primary peritoneal cavity cancer, stage IV primary peritoneal cavity cancer, recurrent fallopian tube cancer, stage IIIA fallopian tube cancer, stage IIIB fallopian tube cancer, stage IIIC fallopian tube cancer, stage IV fallopian tube 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.

  • docetaxelDrug

    Given IV

  • idronoxilDrug

    Given orally

  • placeboOther

    Given orally

Study groups in NCT00303888
Study groupRoleWhat they receive
Arm IExperimentalPatients receive docetaxel IV over 1 hour on days 1, 8, and 15 and oral placebo three times daily on days 1-21.
Receives: Drug: docetaxel; Other: placebo
Arm IIExperimentalPatients receive oral phenoxodiol three times daily on days 1-21 and docetaxel IV over 1 hour on days 1, 8, and 15.
Receives: Drug: docetaxel; Drug: idronoxil

What is being measured

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

  1. Survival (progression-free/recurrence-free interval and overall survival)

  2. Tumor response as assessed by RECIST criteria and clinical examination

  3. Changes in tumor marker CA125 as assessed by Rustin criteria

  4. Safety

Timeline

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

  1. First posted17 Mar 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionAug 2009
  4. Study completionOct 2009

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00303888
Sponsor's protocol ID
0504027640
Other IDs
YALE-HIC-27640, YALE-012705
Status last verified
Jan 2018
First submitted
15 Mar 2006
Last updated
17 Jan 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing docetaxel and idronoxil in people with Fallopian Tube Cancer and Ovarian Cancer, run by Yale University at 1 site in United States.

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: stopped early, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 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.

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 was stopped early. Results are not available in the source record.

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?

Survival (progression-free/recurrence-free interval and overall survival). The study lists 4 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 NCT00303888.

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 17 Jan 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in