NCT00030706

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2002

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.8 years until next milestone

Study Start

First participant enrolled

November 1, 2004

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

2.3 years

First QC Date

February 14, 2002

Last Update Submit

September 27, 2018

Conditions

Ovarian CancerPeritoneal Cavity Cancer

Keywords

stage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerperitoneal cavity cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of clinical remission

    number of participants experience clinical remission will be determined

    up to 12-months post-treatment

Interventions

ixabepiloneDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Gary L. Goldberg, MD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2002

First Posted

January 27, 2003

Study Start

November 1, 2004

Primary Completion

February 1, 2007

Last Updated

September 28, 2018

Record last verified: 2018-09

Locations

US(1)