Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00025155
First received: October 11, 2001
Last updated: June 17, 2015
Last verified: December 2012
  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. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.

Condition Intervention Phase
Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Drug: ixabepilone
Phase 2

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Tumor Response [ Time Frame: Every other cycle until the completion of study treatment with an average of study treatment time as of 3 months. ] [ Designated as safety issue: No ]

    Percentage of participants with complete and partial tumor response as assessed by the Gynecologic Oncology Group Response Evaluation Criteria in Solid Tumors (GOG RECIST) with one-sided 90% Confidence Interval.

    Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion, or a 50% decrease in the LD in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.


  • Frequency and Severity of Observed Adverse Effects [ Time Frame: Every cycle until completion of study treatment up to 30 days after stopping study treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: 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 ] [ Designated as safety issue: No ]

    Progression-Free Survival is the period from study entry until disease progression, death or date of last contact, whichever occurs first.

    Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or a 50% increase in the LD taking as reference the smallest LD recorded since study entry in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression.


  • Overall Survival [ Time Frame: From study entry to death or last contact, up to 5 years of follow-up. ] [ Designated as safety issue: No ]
    Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.


Enrollment: 51
Study Start Date: July 2002
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (ixabepilone)
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.
Drug: ixabepilone
Given IV
Other Names:
  • BMS-247550
  • epothilone B lactam
  • Ixempra

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025155

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: David R. Spriggs Gynecologic Oncology Group
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025155     History of Changes
Other Study ID Numbers: NCI-2012-02413  NCI-2012-02413  CDR0000068927  GOG-0126M  GOG-0126M  U10CA027469 
Study First Received: October 11, 2001
Results First Received: April 29, 2015
Last Updated: June 17, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Peritoneal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Epothilones
Epothilone B
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 25, 2016