Sarcoma
Conditions
Keywords
recurrent uterine sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, uterine carcinosarcoma
Brief summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with persistent or recurrent stage III or stage IV uterine cancer.
Detailed description
OBJECTIVES: * Determine the antitumor activity of paclitaxel and carboplatin in patients with persistent or recurrent stage III or IV uterine carcinosarcoma. * Determine the nature and degree of toxicity of this regimen in these patients. OUTLINE: This is a non-randomized, multicenter study. Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 14-47 patients will be accrued for this study within 20 months.
Interventions
DRUGcarboplatin
DRUGpaclitaxel
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed uterine carcinosarcoma (mixed mesodermal tumor) * Stage III or IV disease * Persistent or recurrent disease * Documented disease progression * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * At least 1 target lesion * Tumors within a previously irradiated field are not considered target lesions unless there is documented disease progression * Ineligible for any higher priority Gynecology Oncology Group (GOG) protocol (i.e., any active GOG phase III protocol for the same patient population) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * GOG 0-2 Life expectancy * Not specified Hematopoietic * Platelet count ≥ 100,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * SGOT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection requiring antibiotics * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer * No sensory or motor neuropathy \> grade 1 PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior cytotoxic chemotherapy for uterine sarcoma Endocrine therapy * At least 1 week since prior hormonal therapy for uterine sarcoma * Concurrent hormone replacement therapy allowed Radiotherapy * See Disease Characteristics Surgery * Not specified Other * Recovered from all prior therapy * No prior anticancer therapy that would preclude study therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nature and Degree of Toxicity | During study treatment and up to 30 days after stopping study treatment | Number of patients who experienced grade 1 or higher serious adverse event (term or group) regardless of attribution using CTCAE v3.0 |
| Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response | Response was measured every other cycle (q 6 weeks) until disease progression is documented. | Primary outcome measured according to RECIST v1.0 Best Response: Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Partial Response (PR) is 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 nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease. |
Countries
Japan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paclitaxel Followed by Carboplatin Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 12 |
| Overall Study | Death | 2 |
| Overall Study | Ineligible | 7 |
| Overall Study | Other, Not Specified | 9 |
| Overall Study | Patient never treated | 2 |
| Overall Study | Refused further treatment | 8 |
Baseline characteristics
| Characteristic | Paclitaxel Followed by Carboplatin |
|---|---|
| Age, Customized Age at Study Entry | 65.5 years STANDARD_DEVIATION 11.6 |
| Sex: Female, Male Female | 46 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 | 46 / 46 |
| serious Total, serious adverse events | 11 / 46 |
Outcome results
Primary
Nature and Degree of Toxicity
Number of patients who experienced grade 1 or higher serious adverse event (term or group) regardless of attribution using CTCAE v3.0
Time frame: During study treatment and up to 30 days after stopping study treatment
Population: Eligible and Evaluable patients
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Grade 0 | Nature and Degree of Toxicity | Other hematologic | 43 Participants |
| Grade 0 | Nature and Degree of Toxicity | Thrombocytopenia | 17 Participants |
| Grade 0 | Nature and Degree of Toxicity | Nausea | 17 Participants |
| Grade 0 | Nature and Degree of Toxicity | Hemorrhage | 43 Participants |
| Grade 0 | Nature and Degree of Toxicity | Neuromotor | 44 Participants |
| Grade 0 | Nature and Degree of Toxicity | Leukopenia | 2 Participants |
| Grade 0 | Nature and Degree of Toxicity | Neutropenia | 1 Participants |
| Grade 0 | Nature and Degree of Toxicity | Anemia | 4 Participants |
| Grade 0 | Nature and Degree of Toxicity | Allergy | 40 Participants |
| Grade 0 | Nature and Degree of Toxicity | Auditory | 43 Participants |
| Grade 0 | Nature and Degree of Toxicity | Cardiovascular | 39 Participants |
| Grade 0 | Nature and Degree of Toxicity | Coagulation | 45 Participants |
| Grade 0 | Nature and Degree of Toxicity | Constitutional | 33 Participants |
| Grade 0 | Nature and Degree of Toxicity | Fatigue | 9 Participants |
| Grade 0 | Nature and Degree of Toxicity | Sensory neuropathy | 14 Participants |
| Grade 0 | Nature and Degree of Toxicity | Alopecia | 8 Participants |
| Grade 0 | Nature and Degree of Toxicity | Dermatologic | 36 Participants |
| Grade 0 | Nature and Degree of Toxicity | Endocrine | 44 Participants |
| Grade 0 | Nature and Degree of Toxicity | Gastrointestinal | 18 Participants |
| Grade 0 | Nature and Degree of Toxicity | Vomiting | 35 Participants |
| Grade 0 | Nature and Degree of Toxicity | Diarrhea | 35 Participants |
| Grade 0 | Nature and Degree of Toxicity | Stomatitis | 35 Participants |
| Grade 0 | Nature and Degree of Toxicity | Genitourinary/renal | 45 Participants |
| Grade 0 | Nature and Degree of Toxicity | Hepatic | 45 Participants |
| Grade 0 | Nature and Degree of Toxicity | Febrile neutropenia | 45 Participants |
| Grade 0 | Nature and Degree of Toxicity | Metabolic | 23 Participants |
| Grade 0 | Nature and Degree of Toxicity | Creatinine | 44 Participants |
| Grade 0 | Nature and Degree of Toxicity | Musculoskeletal | 41 Participants |
| Grade 0 | Nature and Degree of Toxicity | Neurologic | 40 Participants |
| Grade 0 | Nature and Degree of Toxicity | Ocular/visual | 43 Participants |
| Grade 0 | Nature and Degree of Toxicity | Pain | 35 Participants |
| Grade 0 | Nature and Degree of Toxicity | Myalgia | 35 Participants |
| Grade 0 | Nature and Degree of Toxicity | Arthralgia | 36 Participants |
| Grade 0 | Nature and Degree of Toxicity | Pulmonary | 37 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Leukopenia | 4 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Diarrhea | 8 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Thrombocytopenia | 19 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Neutropenia | 3 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Coagulation | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Allergy | 3 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Pulmonary | 5 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Neurologic | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Sensory neuropathy | 15 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Pain | 3 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Constitutional | 8 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Hemorrhage | 1 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Other hematologic | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Nausea | 20 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Musculoskeletal | 2 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Stomatitis | 1 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Auditory | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Fatigue | 14 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Genitourinary/renal | 1 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Anemia | 10 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Myalgia | 3 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Creatinine | 2 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Vomiting | 7 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Alopecia | 7 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Metabolic | 18 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Gastrointestinal | 12 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Febrile neutropenia | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Arthralgia | 4 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Cardiovascular | 3 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Dermatologic | 8 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Endocrine | 2 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Ocular/visual | 2 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Hepatic | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Nature and Degree of Toxicity | Neuromotor | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Hemorrhage | 2 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Endocrine | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Neurologic | 4 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Gastrointestinal | 14 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Stomatitis | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Diarrhea | 2 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Myalgia | 7 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Vomiting | 3 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Genitourinary/renal | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Allergy | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Neutropenia | 3 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Nausea | 8 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Arthralgia | 6 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Auditory | 2 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Leukopenia | 20 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Metabolic | 4 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Other hematologic | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Cardiovascular | 2 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Thrombocytopenia | 5 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Pulmonary | 2 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Coagulation | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Sensory neuropathy | 12 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Constitutional | 4 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Neuromotor | 2 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Musculoskeletal | 2 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Pain | 6 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Ocular/visual | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Fatigue | 19 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Creatinine | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Febrile neutropenia | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Alopecia | 31 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Anemia | 27 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Hepatic | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Nature and Degree of Toxicity | Dermatologic | 2 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Sensory neuropathy | 5 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Neutropenia | 19 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Thrombocytopenia | 3 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Anemia | 3 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Ocular/visual | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Allergy | 3 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Auditory | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Cardiovascular | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Coagulation | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Constitutional | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Pain | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Fatigue | 4 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Alopecia | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Dermatologic | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Pulmonary | 2 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Endocrine | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Gastrointestinal | 2 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Nausea | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Vomiting | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Myalgia | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Diarrhea | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Stomatitis | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Hemorrhage | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Hepatic | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Febrile neutropenia | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Arthralgia | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Metabolic | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Creatinine | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Musculoskeletal | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Other hematologic | 2 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Leukopenia | 19 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Genitourinary/renal | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Neurologic | 2 Participants |
| Grade 3 (CTCAE v 3.0) | Nature and Degree of Toxicity | Neuromotor | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Anemia | 2 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Metabolic | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Coagulation | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Pulmonary | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Cardiovascular | 1 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Arthralgia | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Neuromotor | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Other hematologic | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Dermatologic | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Auditory | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Ocular/visual | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Fatigue | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Alopecia | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Creatinine | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Allergy | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Pain | 2 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Thrombocytopenia | 2 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Genitourinary/renal | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Hemorrhage | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Febrile neutropenia | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Sensory neuropathy | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Vomiting | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Constitutional | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Neutropenia | 20 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Diarrhea | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Leukopenia | 1 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Myalgia | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Nausea | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Gastrointestinal | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Musculoskeletal | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Stomatitis | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Neurologic | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Hepatic | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Nature and Degree of Toxicity | Endocrine | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Endocrine | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Dermatologic | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Leukopenia | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Hemorrhage | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Pain | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Hepatic | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Alopecia | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Neurologic | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Febrile neutropenia | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Sensory neuropathy | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Metabolic | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Fatigue | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Thrombocytopenia | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Creatinine | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Arthralgia | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Constitutional | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Musculoskeletal | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Pulmonary | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Coagulation | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Neutropenia | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Cardiovascular | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Ocular/visual | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Auditory | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Gastrointestinal | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Neuromotor | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Allergy | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Other hematologic | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Genitourinary/renal | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Vomiting | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Nausea | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Diarrhea | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Anemia | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Stomatitis | 0 Participants |
| Grade 5 (CTCAE v.3.0) | Nature and Degree of Toxicity | Myalgia | 0 Participants |
Primary
Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response
Primary outcome measured according to RECIST v1.0 Best Response: Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Partial Response (PR) is 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 nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.
Time frame: Response was measured every other cycle (q 6 weeks) until disease progression is documented.
Population: Total eligible and treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Grade 0 | Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response | Complete Response | 6 participants |
| Grade 0 | Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response | Partial Response | 19 participants |
| Grade 0 | Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response | Stable Disease | 11 participants |
| Grade 0 | Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response | Disease Progression | 6 participants |
| Grade 0 | Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response | Indeterminate | 4 participants |