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A Phase II Evaluation Of Epothilone-B BMS 247550 (IND # 59,669 NSC # 710428) In The Treatment Of Recurrent Or Persistent Platinum And Paclitaxel Refractory Ovarian Or Primary Peritoneal Cancer

Phase 2
Not Enrolling
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

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Trial Information

A Phase II Evaluation Of Epothilone-B BMS 247550 (IND # 59,669 NSC # 710428) In The Treatment Of Recurrent Or Persistent Platinum And Paclitaxel Refractory Ovarian Or Primary Peritoneal Cancer


I. 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.


Patients receive ixabepilone IV over 1 hour. Treatment repeats every 21 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.

Inclusion Criteria:

- 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

- 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 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 ≤ 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency and duration of objective response

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

David R. Spriggs

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

July 2002

Completion Date:

Related Keywords:

  • Primary Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms



Gynecologic Oncology Group Philadelphia, Pennsylvania  19103