Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy
Condition: Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer
MeSH terms: Carcinoma, Ovarian Epithelial
Intervention: ixabepilone
Intervention description: Given IV
Intervention MeSH terms: Epothilones; Epothilone B
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: Female
Healthy volunteers: No

Summary:

      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. Drugs used in chemotherapy work in different ways to stop
      tumor cells from dividing so they stop growing or die.
    

Eligibility criteria:

        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 (Gynecologic Oncology Group) 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 (serum glutamate oxaloacetate transaminase) ≤ 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