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Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy
This study is ongoing, but not recruiting participants.
First Received: October 11, 2001   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025155
  Purpose

RATIONALE: Drugs used in chemotherapy 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 recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not responded to previous chemotherapy.


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

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Frequency and duration of objective response [ Designated as safety issue: No ]
  • Frequency and severity of observed adverse effects [ Designated as safety issue: Yes ]
  • Survival time [ Designated as safety issue: No ]
  • Duration of progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 51
Study Start Date: July 2002
Detailed Description:

OBJECTIVES:

  • Determine the antitumor activity of ixabepilone in patients with recurrent or persistent platinum and paclitaxel-refractory ovarian epithelial or primary peritoneal cancer.
  • Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: 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.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 6-12 months.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial cancer or primary peritoneal cancer

    • Recurrent or persistent disease
    • Platinum AND taxane-resistant or refractory disease

      • Progressed during therapy OR
      • 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

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic:

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal:

  • Creatinine ≤ 1.5 times ULN

Neurologic:

  • No sensory or motor neuropathy > grade 1
  • No dementia or altered mental status

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior biologic therapy
  • At least 3 weeks since prior immunotherapy

Chemotherapy:

  • See Disease Characteristics
  • Must have received:

    • 1 prior combination taxane-based and platinum-based chemotherapy regimen OR
    • 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

Endocrine therapy:

  • At least 1 week since prior hormonal anticancer therapy
  • Concurrent hormone replacement therapy allowed

Radiotherapy:

  • 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

Surgery:

  • Recovered from recent surgery

Other:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025155

  Show 32 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: David R. Spriggs, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068927, GOG-0126M
Study First Received: October 11, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00025155     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
peritoneal cavity cancer

Study placed in the following topic categories:
Epothilone B
Ovarian Neoplasms
Digestive System Neoplasms
Gonadal Disorders
Epothilones
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Ovarian Diseases
Ovarian Epithelial Cancer
Abdominal Neoplasms
Recurrence
Genital Diseases, Female
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Peritoneal Diseases
Ovarian Cancer
Gastrointestinal Neoplasms
Endocrinopathy
Peritoneal Neoplasms
Endocrine Gland Neoplasms

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 September 02, 2009