search
Back to results

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

Primary Purpose

Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ixabepilone
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Peritoneal Cavity Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (ixabepilone)

Arm Description

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.

Outcomes

Primary Outcome Measures

Tumor Response
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.
Number of People With Adverse Effects

Secondary Outcome Measures

Progression Free Survival
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
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

Full Information

First Posted
October 11, 2001
Last Updated
July 22, 2019
Sponsor
National Cancer Institute (NCI)
Collaborators
Gynecologic Oncology Group
search

1. Study Identification

Unique Protocol Identification Number
NCT00025155
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
Collaborators
Gynecologic Oncology Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (ixabepilone)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ixabepilone
Other Intervention Name(s)
BMS-247550, epothilone B lactam, Ixempra
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Tumor Response
Description
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.
Time Frame
Every other cycle until the completion of study treatment with an average of study treatment time as of 3 months.
Title
Number of People With Adverse Effects
Time Frame
Every cycle until completion of study treatment up to 30 days after stopping study treatment
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
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.
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
Title
Overall Survival
Description
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Time Frame
From study entry to death or last contact, up to 5 years of follow-up.

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R. Spriggs
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs