Endometrial Adenocarcinoma, Recurrent Endometrial Carcinoma, Stage IV Endometrial Carcinoma
Conditions
Brief summary
Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well ixabepilone works in treating patients with recurrent or persistent endometrial cancer.
Detailed description
PRIMARY OBJECTIVES: I. Determine the response rate in patients with recurrent or persistent endometrial adenocarcinoma treated with ixabepilone. II. Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. 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 2.5 years.
Interventions
DRUGixabepilone
Given IV
Sponsors
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed endometrial adenocarcinoma * Recurrent or persistent disease * Histologic confirmation of the original primary tumor is required * Not amenable to management with any of the following: * Surgery * Radiotherapy * Higher priority or standard chemotherapy * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan * At least 1 target lesion * Tumors within a previously irradiated field are designated as non-target lesions * Disease in an irradiated field as the only site of measurable disease is acceptable as a target lesion only if there has been clear progression of the lesion at least 90 days after completion of radiotherapy * Received 1, and only 1, prior chemotherapy regimen (e.g., high-dose therapy, consolidation, or extended therapy administered after surgery or non-surgical assessment) for management of endometrial adenocarcinoma * Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (e.g., any active GOG phase III study for the same patient population) * 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) * AST (aspartate aminotransferase) ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * Creatinine ≤ 1.5 times ULN * Sensory or motor neuropathy ≤ grade 1 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection requiring antibiotics * No other invasive malignancies within the past 5 years except non-melanoma skin cancer * At least 3 weeks since prior biologic or immunologic agents directed at the malignant tumor * One prior non-cytotoxic\* (biologic or cytostatic) regimen for management of recurrent or persistent disease allowed * See Disease Characteristics * Prior paclitaxel or docetaxel allowed * Recovered from prior chemotherapy * No more than 1 prior cytotoxic chemotherapy regimen (either single or combination drug therapy) * No prior ixabepilone * At least 1 week since prior hormonal therapy directed at the malignant tumor * Continuation of hormone replacement therapy allowed * See Disease Characteristics * Recovered from prior radiotherapy * Recovered from prior surgery * At least 3 weeks since other prior therapy directed at the malignant tumor * No prior cancer treatment that contraindicates study therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response | Every other cycle for first 6 months; then every six months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease | RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate. |
| Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Every cycle until completion of study treatment up to 30 days after stopping study treatment (average length of data collection = 4 months) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up. | Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. |
| Overall Survival | From study entry to death or last contact, up to 5 years of follow-up. | Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. |
Countries
United States
Participant flow
Recruitment details
The study was activated on 5/2/2005 and closed to accrual on 1/3/2008 (suspended from 4/3/2006 to 4/1/2007).
Participants by arm
| Arm | Count |
|---|---|
| Ixabepilone Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible: Second primary cancer site | 2 |
Baseline characteristics
| Characteristic | Ixabepilone |
|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 9.4 |
| Age, Customized 20-29 years | 0 participants |
| Age, Customized 30-39 years | 0 participants |
| Age, Customized 40-49 years | 2 participants |
| Age, Customized 50-59 years | 11 participants |
| Age, Customized 60-69 years | 19 participants |
| Age, Customized 70-79 years | 16 participants |
| Age, Customized 80-89 years | 2 participants |
| Histologic Type Adenocarcinoma, Unspecified | 1 participants |
| Histologic Type Carcinosarcoma-homologous | 1 participants |
| Histologic Type Clear Cell Carcinoma | 1 participants |
| Histologic Type Endometrioid Adenocarcinoma | 22 participants |
| Histologic Type Mixed Epithelial Carcinoma | 4 participants |
| Histologic Type Serous Adenocarcinoma | 21 participants |
| International Federation of Gynecology and Obstetrics (FIGO) Stage Recurrent/Persistent | 50 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 50 / 50 |
| serious Total, serious adverse events | 25 / 50 |
Outcome results
Primary
Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
Time frame: Every cycle until completion of study treatment up to 30 days after stopping study treatment (average length of data collection = 4 months)
Population: Eligible and treated patients
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Leukopenia | 9 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Thrombocytopenia | 13 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Pulmonary | 10 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Coagulation | 0 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Cardiac | 1 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Allergy/Immunology | 4 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Pain | 9 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Auditory/ear | 0 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Neurosensory | 19 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Genitourinary | 1 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Ocular/visual | 3 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Other neurologic | 4 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Musculoskeletal | 3 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Metabolic | 9 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Lymphatics | 8 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Neutropenia | 5 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Vascular | 0 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Infection | 0 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Hemorrhage | 1 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Gastrointestinal | 11 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Anemia | 12 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Alopecia | 7 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Dermatologic | 7 Participants |
| Ixabepilone | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Constitutional | 15 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Coagulation | 0 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Leukopenia | 14 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Genitourinary | 1 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Neurosensory | 7 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Neutropenia | 7 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Anemia | 29 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Thrombocytopenia | 4 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Allergy/Immunology | 0 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Auditory/ear | 2 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Cardiac | 0 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Constitutional | 14 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Dermatologic | 21 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Gastrointestinal | 15 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Hemorrhage | 1 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Infection | 2 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Lymphatics | 2 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Metabolic | 8 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Musculoskeletal | 4 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Other neurologic | 3 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Ocular/visual | 3 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Pain | 8 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Pulmonary | 4 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Alopecia | 23 Participants |
| Grade 2 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Vascular | 1 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Musculoskeletal | 0 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Infection | 8 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Dermatologic | 2 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Neurosensory | 4 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Other neurologic | 4 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Constitutional | 9 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Lymphatics | 0 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Thrombocytopenia | 1 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Leukopenia | 17 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Cardiac | 2 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Alopecia | 0 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Metabolic | 3 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Vascular | 0 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Gastrointestinal | 12 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Coagulation | 1 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Genitourinary | 0 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Anemia | 6 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Auditory/ear | 0 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Allergy/Immunology | 0 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Pain | 3 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Hemorrhage | 2 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Pulmonary | 2 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Ocular/visual | 0 Participants |
| Grade 3 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Neutropenia | 14 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Neutropenia | 12 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Anemia | 1 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Constitutional | 1 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Dermatologic | 0 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Pulmonary | 0 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Gastrointestinal | 0 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Genitourinary | 0 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Hemorrhage | 0 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Infection | 0 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Vascular | 1 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Lymphatics | 0 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Leukopenia | 7 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Metabolic | 1 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Alopecia | 0 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Neurosensory | 0 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Other neurologic | 1 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Ocular/visual | 0 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Pain | 0 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Allergy/Immunology | 0 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Auditory/ear | 0 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Thrombocytopenia | 1 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Musculoskeletal | 0 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Cardiac | 0 Participants |
| Grade 4 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Coagulation | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Gastrointestinal | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Hemorrhage | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Anemia | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Ocular/visual | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Musculoskeletal | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Vascular | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Pulmonary | 1 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Neutropenia | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Constitutional | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Allergy/Immunology | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Coagulation | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Pain | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Genitourinary | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Metabolic | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Lymphatics | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Cardiac | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Auditory/ear | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Neurosensory | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Thrombocytopenia | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Alopecia | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Leukopenia | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Dermatologic | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Other neurologic | 0 Participants |
| Grade 5 | Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) | Infection | 0 Participants |
Primary
Tumor Response
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Time frame: Every other cycle for first 6 months; then every six months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease
Population: Eligible and Treated Patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ixabepilone | Tumor Response | 12 percentage of participants |
Secondary
Overall Survival
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.
Population: Eligible and treated patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ixabepilone | Overall Survival | 8.8 months |
Secondary
Progression-free Survival
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Time frame: From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.
Population: Eligible and Treated Patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ixabepilone | Progression-free Survival | 3.1 months |