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

Sponsor:	Albert Einstein College of Medicine of Yeshiva University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00030706

Purpose

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.

Condition	Intervention	Phase
Ovarian Cancer Peritoneal Cavity Cancer	Drug: ixabepilone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Study Of Epothilone B Analogue BMS-247550 In Relapse And/Or Refractory Stage III Or IV Ovarian Epithelial Cancer, Following Front-Line Treatment With Platinum Plus Taxane-Based Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Ixabepilone

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Incidence of clinical remission [ Designated as safety issue: No ]

Study Start Date:

November 2004

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030706

Locations

United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461

Sponsors and Collaborators

Albert Einstein College of Medicine of Yeshiva University

National Cancer Institute (NCI)

Investigators

Study Chair:

Gary L. Goldberg, MD

Albert Einstein College of Medicine of Yeshiva University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000069190, AECM-3632, MCC-12602, NCI-3632
Study First Received:	February 14, 2002
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00030706 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Digestive System Neoplasms
Ovarian Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Epothilones
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Ovarian Diseases

Abdominal Neoplasms
Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Digestive System Diseases
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Peritoneal Diseases
Peritoneal Neoplasms
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009