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Primary Peritoneal Cavity CancerPhase 2NCT00025155

Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy

A Phase 2 study testing ixabepilone in people with Primary Peritoneal Cavity Cancer and Recurrent Ovarian Epithelial Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

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

Phase II trial to study the effectiveness of ixabepilone in treating patients who have recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not responded to previous chemotherapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Any age, women only
What is being tested?
ixabepilone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
Jul 2002to Mar 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically confirmed ovarian epithelial cancer or primary peritoneal cancer
  • Recurrent or persistent disease
  • Platinum AND taxane-resistant or refractory disease
  • Progressed during therapy
  • Refractory disease within 6 months of therapy
  • Measurable disease
Show all 46Show fewer
  • At least 20 mm by conventional techniques
  • At least 10 mm by spiral CT scan
  • Tumor lesions located within a previously irradiated field are not considered measurable disease unless there is documented tumor progression in these lesions or biopsy confirmation ≥ 90 days following completion of radiotherapy
  • Ineligible for higher priority GOG (Gynecologic Oncology Group) protocol
  • No active brain metastases
  • Performance status - GOG 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT (serum glutamate oxaloacetate transaminase) ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • No sensory or motor neuropathy > grade 1
  • No dementia or altered mental status
  • No other serious uncontrolled medical disorder
  • No active infection requiring antibiotics
  • No prior hypersensitivity reaction to paclitaxel or other therapy containing Cremophor EL
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • At least 3 weeks since prior biologic therapy
  • At least 3 weeks since prior immunotherapy
  • Must have received:
  • 1 prior combination taxane-based and platinum-based chemotherapy regimen
  • 1 prior platinum-based chemotherapy regimen AND 1 prior taxane-based chemotherapy regimen
  • Initial treatment may include high-dose therapy, consolidation, or extended therapy
  • At least 3 weeks since prior chemotherapy and recovered
  • No prior ixabepilone
  • No other prior cytotoxic chemotherapy for recurrent or persistent disease, including treatment with initial regimen
  • At least 1 week since prior hormonal anticancer therapy
  • Concurrent hormone replacement therapy allowed
  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to site(s) of measurable disease
  • No radiotherapy to > 25% of marrow-containing areas
  • Recovered from recent surgery
  • At least 3 weeks since other anticancer therapy
  • No prior anticancer therapy that precludes study participation
  • No concurrent food supplements (e.g., St. John's wort)
  • No concurrent amifostine or other protective agents

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Gynecologic Oncology Group

    Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

Official title: A Phase II Evaluation of Epothilone-B BMS 247550 (NSC # 710428) in the Treatment of Recurrent or Persistent Platinum and Paclitaxel Refractory Ovarian or Primary Peritoneal Cancer

Phase II trial to study the effectiveness of ixabepilone in treating patients who have recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not responded to previous chemotherapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the antitumor activity of ixabepilone in patients with recurrent or persistent platinum and paclitaxel-refractory ovarian epithelial or primary peritoneal cancer.

II. Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE:

Patients receive ixabepilone IV over 1 hour. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Being tested
ixabepilone
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

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

  • ixabepiloneDrug

    Also called BMS-247550, epothilone B lactam, Ixempra

    Given IV

Study groups in NCT00025155
Study groupRoleWhat they receive
Treatment (ixabepilone)ExperimentalPatients receive ixabepilone IV over 1 hour. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
Receives: Drug: ixabepilone

What is being measured

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

  1. Tumor Response

    Percentage of participants with complete and partial tumor response as assessed by the Gynecologic Oncology Group Response Evaluation Criteria in Solid Tumors (GOG RECIST) with one-sided 90% Confidence Interval.

    Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion, or a 50% decrease in the LD in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.

    Measured: Every other cycle until the completion of study treatment with an average of study treatment time as of 3 months.

  2. Number of People With Adverse Effects

    Measured: Every cycle until completion of study treatment up to 30 days after stopping study treatment

Secondary outcomes (2)

  1. Progression Free Survival

    Progression-Free Survival is the period from study entry until disease progression, death or date of last contact, whichever occurs first.

    Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or a 50% increase in the LD taking as reference the smallest LD recorded since study entry in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression.

    Measured: From study entry to disease progression, death or date of last contact, whichever occurs first. Every other cycle, up to 5 years of follow-up

  2. Overall Survival

    Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

    Measured: From study entry to death or last contact, up to 5 years of follow-up.

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startJul 2002
  3. Primary completionMar 2010
  4. Study completionMar 2010

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00025155
Sponsor's protocol ID
NCI-2012-02413
Other IDs
NCI-2012-02413, CDR0000068927, GOG-0126M, GOG-0126M, U10CA027469
Status last verified
Jul 2019
First submitted
11 Oct 2001
Last updated
24 Jul 2019

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ixabepilone in people with Primary Peritoneal Cavity Cancer and Recurrent Ovarian Epithelial Cancer, run by National Cancer Institute (NCI) 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?

The sponsor lists 46 inclusion and 0 exclusion criteria. 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 24 Jul 2019. 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 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?

Yes. Results are posted in the registry (first posted 13 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Tumor Response (time frame: Every other cycle until the completion of study treatment with an average of study treatment time as of 3 months.). 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 NCT00025155.

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 24 Jul 2019.

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