Recurrent Uterine Corpus Sarcoma, Uterine Corpus Leiomyosarcoma
Conditions
Brief summary
This phase II trial is studying the side effects and how well ixabepilone works in treating patients with recurrent or persistent leiomyosarcoma of the uterus previously treated with chemotherapy. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Detailed description
PRIMARY OBJECTIVES: I. To determine the response rate (complete and partial responses by RECIST 1.1) of ixabepilone in patients with recurrent or persistent leiomyosarcoma of the uterus who have failed one previous chemotherapy regimen. II. To determine the nature and degree of toxicity of ixabepilone as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 in this cohort of patients. SECONDARY OBJECTIVES: I. To determine the duration of progression-free survival (PFS) and overall survival (OS). II. To determine the level of beta-III tubulin expression measured by IHC in women with leiomyosarcoma. III. To determine if beta-III tubulin expression as measured by IHC predicts response to ixabepilone in women with leiomyosarcoma. OUTLINE: Patients receive ixabepilone intravenously (IV) over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Interventions
DRUGIxabepilone
Given IV
OTHERLaboratory Biomarker Analysis
Correlative studies
Sponsors
NRG Oncology
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed uterine leiomyosarcoma * Persistent or recurrent disease that is refractory to curative or established treatments * Histologic confirmation of the original primary tumor is required * Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) * Each lesion must be ≥ 10 mm by CT scan, MRI, or caliper measurement by clinical exam OR ≥ 20 mm by chest x-ray * Lymph nodes must be ≥ 15 mm in short axis by CT scan or MRI * Must have ≥ 1 target lesion to assess response * Tumors within a previously irradiated field will be designated as non-target lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days following completion of radiotherapy * Not eligible for a higher priority GOG protocol, if one exists * Must have had 1 prior cytotoxic regimen that included a taxane regimen for management of leiomyosarcoma * Single-agent or multi-agent therapy allowed * Patients who did not receive prior therapy with a taxane (e.g., docetaxel) must receive a second regimen that includes a taxane * No known brain metastases * GOG performance status 0-2 * Life expectancy \> 6 months * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * AST ≤ 3 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * Peripheral neuropathy (sensory or mother) ≤ grade 1 * Negative pregnancy test * Not pregnant or nursing * Fertile patients must use effective contraception prior to and for the duration of study participation * Free of active infection requiring antibiotics * Uncomplicated urinary tract infection allowed * No other invasive malignancy except non-melanoma skin cancer or curatively treated localized cancer of the breast, head and neck, or skin that was completed more than 3 years ago and the patient remains free of recurrence or metastatic disease * No history of a severe hypersensitivity reaction to agents containing Cremophor EL or its derivatives (e.g., polyoxyethylated castor oil) * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina * Cardiac arrhythmia * Psychiatric illness and/or social situations that would limit compliance with study requirements * No concurrent amifostine or other protective agents * Recovered from effects of recent surgery, radiotherapy, or chemotherapy * At least 1 week since prior hormonal therapy * Hormonal therapy (cytotoxic or non-cytotoxic) not counted as prior regimen * At least 3 weeks since any other prior therapy directed to the malignant tumor, including immunologic agents * At least 4 weeks since prior radiation therapy * One prior non-cytotoxic (biologic or cytostatic) regimen, administered as part of the previous cytotoxic regimen or in addition to it, allowed * Non-cytotoxic agents include, but are not limited to, the following: * Monoclonal antibodies * Cytokines * Small-molecule inhibitors of signal transduction * More than 3 years since radiotherapy for localized cancer of the breast, head and neck, or skin provided patient remains free of recurrence or metastatic disease * No prior ixabepilone * No prior chemotherapy for any abdominal or pelvic tumor other than for the treatment of uterine leiomyosarcoma within the past 3 years * Prior chemotherapy for localized breast cancer allowed provided it was completed more than 3 years ago and patient remains free of recurrent or metastatic disease * No other concurrent investigational agents * No concurrent strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine, voriconazole, or grapefruit juice) or CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifampicin, rifabutin, phenobarbital, or St. John wort) * No concurrent combination antiretroviral therapy for HIV-positive patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response | Every other cycle for the first 6 months; then every 3 months thereafter; up to 5 years. | Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. 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 Adverse Events as Assessed by NCI CTCAE v. 4.0 | Every cycle until completion of study treatment up to 30 days after stopping study treatment | — |
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-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression. |
| 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
Participants by arm
| Arm | Count |
|---|---|
| Ixabepilone Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible-Never treated | 1 |
| Overall Study | Ineligible- Wrong cell type | 1 |
| Overall Study | Ineligible-Wrong primary cancer site | 1 |
Baseline characteristics
| Characteristic | Ixabepilone |
|---|---|
| Age, Continuous | 55.5 years STANDARD_DEVIATION 7.1 |
| Age, Customized 40-49 years | 5 participants |
| Age, Customized 50-59 years | 12 participants |
| Age, Customized 60-69 years | 6 participants |
| Histologic Type Carcinosarcoma, malignant mixed Mullerian tumor | 1 participants |
| Histologic Type Leiomyosarcoma | 22 participants |
| Sex: Female, Male Female | 23 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 | 23 / 23 |
| serious Total, serious adverse events | 9 / 23 |
Outcome results
Primary
Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0
Time frame: Every cycle until completion of study treatment up to 30 days after stopping study treatment
Population: Eligible and evaluable patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ixabepilone | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Leukopenia | 5 Participants |
| Ixabepilone | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Myalgia | 20 Participants |
| Ixabepilone | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Anemia | 2 Participants |
| Ixabepilone | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Musculoskeletal/Connective tissue | 19 Participants |
| Ixabepilone | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Vomiting | 19 Participants |
| Ixabepilone | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Nausea | 16 Participants |
| Ixabepilone | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Platelet count decreased | 17 Participants |
| Ixabepilone | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Alopecia | 13 Participants |
| Ixabepilone | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Fatigue | 10 Participants |
| Ixabepilone | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Diarrhea | 18 Participants |
| Ixabepilone | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Neutropenia | 8 Participants |
| Ixabepilone | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Constipation | 15 Participants |
| Ixabepilone | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Perpheral sensory neuropathy | 17 Participants |
| Ixabepilone | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Anorexia | 19 Participants |
| Ixabepilone | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Dyspnea | 19 Participants |
| Ixabepilone | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Dizziness | 20 Participants |
| Ixabepilone | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Thrombocytopenia | 17 Participants |
| Ixabepilone | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Mucositis | 20 Participants |
| Grade 1 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Leukopenia | 5 Participants |
| Grade 1 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Dizziness | 3 Participants |
| Grade 1 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Musculoskeletal/Connective tissue | 3 Participants |
| Grade 1 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Myalgia | 2 Participants |
| Grade 1 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Perpheral sensory neuropathy | 4 Participants |
| Grade 1 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Neutropenia | 4 Participants |
| Grade 1 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Alopecia | 4 Participants |
| Grade 1 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Anemia | 10 Participants |
| Grade 1 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Platelet count decreased | 6 Participants |
| Grade 1 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Nausea | 4 Participants |
| Grade 1 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Vomiting | 3 Participants |
| Grade 1 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Dyspnea | 2 Participants |
| Grade 1 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Mucositis | 2 Participants |
| Grade 1 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Constipation | 7 Participants |
| Grade 1 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Thrombocytopenia | 6 Participants |
| Grade 1 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Diarrhea | 5 Participants |
| Grade 1 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Fatigue | 10 Participants |
| Grade 1 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Anorexia | 2 Participants |
| Grade 2 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Alopecia | 6 Participants |
| Grade 2 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Musculoskeletal/Connective tissue | 1 Participants |
| Grade 2 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Dyspnea | 1 Participants |
| Grade 2 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Mucositis | 0 Participants |
| Grade 2 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Diarrhea | 0 Participants |
| Grade 2 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Anemia | 6 Participants |
| Grade 2 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Thrombocytopenia | 0 Participants |
| Grade 2 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Neutropenia | 4 Participants |
| Grade 2 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Leukopenia | 6 Participants |
| Grade 2 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Myalgia | 1 Participants |
| Grade 2 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Platelet count decreased | 0 Participants |
| Grade 2 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Perpheral sensory neuropathy | 2 Participants |
| Grade 2 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Fatigue | 1 Participants |
| Grade 2 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Dizziness | 0 Participants |
| Grade 2 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Constipation | 1 Participants |
| Grade 2 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Anorexia | 2 Participants |
| Grade 2 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Nausea | 3 Participants |
| Grade 2 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Vomiting | 1 Participants |
| Grade 3 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Nausea | 0 Participants |
| Grade 3 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Vomiting | 0 Participants |
| Grade 3 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Alopecia | 0 Participants |
| Grade 3 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Fatigue | 2 Participants |
| Grade 3 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Neutropenia | 3 Participants |
| Grade 3 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Thrombocytopenia | 0 Participants |
| Grade 3 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Mucositis | 1 Participants |
| Grade 3 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Perpheral sensory neuropathy | 0 Participants |
| Grade 3 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Constipation | 0 Participants |
| Grade 3 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Myalgia | 0 Participants |
| Grade 3 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Anorexia | 0 Participants |
| Grade 3 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Diarrhea | 0 Participants |
| Grade 3 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Dizziness | 0 Participants |
| Grade 3 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Platelet count decreased | 0 Participants |
| Grade 3 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Leukopenia | 5 Participants |
| Grade 3 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Dyspnea | 1 Participants |
| Grade 3 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Anemia | 5 Participants |
| Grade 3 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Musculoskeletal/Connective tissue | 0 Participants |
| Grade 4 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Dizziness | 0 Participants |
| Grade 4 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Leukopenia | 2 Participants |
| Grade 4 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Thrombocytopenia | 0 Participants |
| Grade 4 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Neutropenia | 4 Participants |
| Grade 4 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Anemia | 0 Participants |
| Grade 4 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Platelet count decreased | 0 Participants |
| Grade 4 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Nausea | 0 Participants |
| Grade 4 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Vomiting | 0 Participants |
| Grade 4 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Mucositis | 0 Participants |
| Grade 4 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Constipation | 0 Participants |
| Grade 4 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Diarrhea | 0 Participants |
| Grade 4 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Fatigue | 0 Participants |
| Grade 4 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Anorexia | 0 Participants |
| Grade 4 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Musculoskeletal/Connective tissue | 0 Participants |
| Grade 4 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Myalgia | 0 Participants |
| Grade 4 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Perpheral sensory neuropathy | 0 Participants |
| Grade 4 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Dyspnea | 0 Participants |
| Grade 4 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Alopecia | 0 Participants |
| Grade 5 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Musculoskeletal/Connective tissue | 0 Participants |
| Grade 5 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Anorexia | 0 Participants |
| Grade 5 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Fatigue | 0 Participants |
| Grade 5 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Diarrhea | 0 Participants |
| Grade 5 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Constipation | 0 Participants |
| Grade 5 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Dizziness | 0 Participants |
| Grade 5 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Mucositis | 0 Participants |
| Grade 5 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Vomiting | 0 Participants |
| Grade 5 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Nausea | 0 Participants |
| Grade 5 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Platelet count decreased | 0 Participants |
| Grade 5 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Alopecia | 0 Participants |
| Grade 5 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Dyspnea | 0 Participants |
| Grade 5 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Anemia | 0 Participants |
| Grade 5 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Neutropenia | 0 Participants |
| Grade 5 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Thrombocytopenia | 0 Participants |
| Grade 5 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Myalgia | 0 Participants |
| Grade 5 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Leukopenia | 0 Participants |
| Grade 5 (CTCAE v 4.0) | Frequency and Severity of Adverse Events as Assessed by NCI CTCAE v. 4.0 | Perpheral sensory neuropathy | 0 Participants |
Primary
Tumor Response
Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. 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 the first 6 months; then every 3 months thereafter; up to 5 years.
Population: Eligible and treated patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ixabepilone | Tumor Response | 0 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 | 7.6 months |
Secondary
Progression-free Survival
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.
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 | 1.4 months |