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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Female
Ovarian Cancer, Peritoneal Cavity Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of clinical remission

Safety Issue:

No

Principal Investigator

Gary L. Goldberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University

Authority:

United States: Federal Government

Study ID:

CDR0000069190

NCT ID:

NCT00030706

Start Date:

November 2004

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461