Clinical trial NCT00025155: Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy
Official title: A Phase II Evaluation of Epothilone-B BMS 247550 (NSC # 710428) in the Treatment of Recurrent or Persistent Platinum and Paclitaxel Refractory Ovarian or Primary Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: Gynecologic Oncology Group
First posted: 2003-01-27
Enrollment: 51
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: PRIMARY OBJECTIVES:

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.

OUTLINE:

Patients receive ixabepilone IV over 1 hour. Treatment repeats every 28 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.

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

Primary outcomes:
measure: Tumor Response
timeFrame: Every other cycle until the completion of study treatment with an average of study treatment time as of 3 months.
measure: Number of People With Adverse Effects
timeFrame: Every cycle until completion of study treatment up to 30 days after stopping study treatment
Secondary outcomes:
measure: Progression Free Survival
timeFrame: From study entry to disease progression, death or date of last contact, whichever occurs first. Every other cycle, up to 5 years of follow-up
measure: Overall Survival
timeFrame: From study entry to death or last contact, up to 5 years of follow-up.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gynecologic Oncology Group
state: Pennsylvania
Study officials:
affiliation: Gynecologic Oncology Group
name: David R. Spriggs
role: PRINCIPAL_INVESTIGATOR
References: