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CompletedNCT00030706Updated Sep 28, 2018

Ixabepilone in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer

A Phase 2 interventional study of ixabepilone in Ovarian Cancer and Peritoneal Cavity Cancer, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-09-28.

Sponsored by Montefiore Medical Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Feb 2007, 19 years 8 months ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who have relapsed and/or refractory stage III or stage IV ovarian epithelial cancer or primary peritoneal cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the antitumor activity of ixabepilone, in terms of clinical response and progression-free survival, in patients with relapsed and/or refractory stage III or IV ovarian epithelial or primary peritoneal cancer.
  • Determine the nature and degree of toxicity of this drug in these patients.

Secondary

  • Correlate pre-ixabepilone survivin mRNA and protein levels in patient-derived ovarian cancer cells with quality of response (i.e., at least partial response vs no response).
  • Correlate CYP3A4 (3A4*1B), 3A5 (3A5*1), and 3A7 (ER6 p variation) allelic polymorphisms with parent drug kinetic parameters, toxicity, and efficacy of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive ixabepilone IV over 1 hour once weekly on weeks 1-3. Treatment repeats every 4 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12 months.

02

Conditions studied

  • Ovarian Cancer
  • Peritoneal Cavity Cancer

Keywords

  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • peritoneal cavity cancer
03

In context

Ovarian Neoplasms

2,757 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.

Browse Ovarian Neoplasms studies →

Lead sponsor

Montefiore Medical Center is the lead sponsor of 414 studies on the registry; 69 are open to participants now.

Of its 86 completed or terminated interventional studies of FDA-regulated products, 76 (88%) have results posted.

Browse Montefiore Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal carcinoma

    • Recurrent or refractory disease

      • Previously treated with 1, and only 1, prior chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound and paclitaxel or docetaxel
      • Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment

  • Bidimensionally measurable disease by physical exam, CT scan, or MRI

    • Ascites and pleural effusions are not measurable disease
    • No prior irradiation to indicator lesions

PATIENT CHARACTERISTICS:

Age

  • 18 to 75

Performance status

  • GOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • No prior bleeding disorder or unexplained bleeding

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT/SGPT no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal

  • Creatinine no greater than 1.5 times ULN

Other

  • No active infection requiring antibiotics
  • No grade 2 or greater neuropathy (sensory and motor)
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • No prior recurrent grade 2 or greater hypersensitivity reactions to Cremophor EL, docetaxel, or paclitaxel
  • No other medical condition that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 3 weeks since prior biologic or immunologic therapy for ovarian epithelial or primary peritoneal carcinoma

Chemotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy and recovered
  • No prior ixabepilone
  • No prior cytotoxic chemotherapy (including retreatment with initial chemotherapy regimens) for recurrent or persistent ovarian epithelial or primary peritoneal carcinoma

Endocrine therapy

  • At least 1 week since prior hormonal therapy for ovarian epithelial or primary peritoneal carcinoma
  • Concurrent hormonal replacement therapy allowed

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to a site of measurable disease used on study
  • No prior radiotherapy to more than 25% of bone marrow

Surgery

  • See Disease Characteristics
  • Recovered from prior surgery

Other

  • At least 3 weeks since other prior therapies for ovarian epithelial or primary peritoneal carcinoma
  • No prior cancer treatment for other invasive malignancies that would preclude study participation
  • No concurrent heparin or other anticoagulants
  • No concurrent Hypericum perforatum (St. John's wort) or any product containing this compound
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)

Interventions

06

What researchers measure

Primary outcomes

  1. Incidence of clinical remission

    number of participants experience clinical remission will be determined

    Time frame: up to 12-months post-treatment

07

Study locations

1 site
  • Albert Einstein Cancer Center at Albert Einstein College of Medicine
    The Bronx, New York 10461, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2004 to primary completion in Feb 2007, 27 months.

Of 203 non-industry phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 82. This study's 27 months is below that.

Counting every sponsor, half of 307 studies reached it within 47 months; a quarter within 33 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2002
First posted
Jan 27, 2003
StartActual
Nov 2004
Primary completionActual
Feb 2007
Last update
Sep 28, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00030706
Lead sponsor
Montefiore Medical Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Nov 2004
Primary completion
Feb 2007
Last update
Sep 28, 2018

Study contacts

Gary L. Goldberg, MD
principal investigator · Albert Einstein College of Medicine

Oversight

FDA-regulated drug
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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