Sarcoma
Conditions
Keywords
uterine leiomyosarcoma, recurrent uterine sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma
Brief summary
RATIONALE: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well trabectedin works in treating patients with advanced, persistent, or recurrent leiomyosarcoma of the uterus.
Detailed description
OBJECTIVES: * Determine the antitumor activity of trabectedin, as measured by frequency and duration of objective response, in patients with advanced, persistent, or recurrent uterine leiomyosarcoma. * Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: This is a nonrandomized, multicenter study. Patients receive trabectedin IV continuously over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve a confirmed complete response may receive at least 2 additional courses. After completion of study treatment, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Interventions
DRUGtrabectedin
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Allocation
NON_RANDOMIZED
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 leiomyosarcoma * Histological confirmation of original primary tumor required * Advanced, persistent, or recurrent disease * Documented disease progression * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, and MRI OR ≥ 10 mm by spiral CT scan * At least 1 target lesion * Tumors within a previously irradiated field are considered nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiotherapy * Ineligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population) PATIENT CHARACTERISTICS: * GOG performance status 0-2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Platelet count ≥ 100,000/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Hemoglobin \> 9.0 g/dL * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Bilirubin normal * AST ≤ 2.5 times ULN * Alkaline phosphatase ≤ 1.5 times ULN * CPK ≤ ULN * No active infection requiring antibiotics (except for patients with uncomplicated UTI) * No neuropathy (sensory or motor) \> grade 1 * No other invasive malignancy within the past 5 years except for nonmelanoma skin cancer * No known active liver disease or hepatitis * Must be willing/able to have a central venous catheter PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior surgery, radiotherapy, or other therapy * No prior cancer treatment that would preclude study therapy * No prior cytotoxic chemotherapy or biologic therapy for uterine sarcoma * No prior chemotherapy for any abdominal or pelvic tumor within the past 5 years * Prior adjuvant chemotherapy for localized breast cancer is allowed provided it was completed more than 3 years ago and there is no evidence of recurrent or metastatic disease * No prior trabectedin * No prior radiotherapy within the past 5 years to any portion of the abdominal cavity or pelvis other than for treatment of uterine sarcoma * Prior radiotherapy for localized cancer of the breast, head and neck or skin is allowed, provided that it was completed more than 3 years ago and there is no evidence of recurrent or metastatic disease * At least 1 week since prior hormonal therapy for the malignancy (continuation of hormone replacement therapy is permitted) * No concurrent amifostine or other protective agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 | CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years. | 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. |
| Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up | — |
Countries
United States
Participant flow
Recruitment details
This trial was opened to patient entry on June 4, 2007 and was closed to accrual on November 3, 2008.
Participants by arm
| Arm | Count |
|---|---|
| Trabectidin Trabectedin 1.5 mg/m2 IV over 24 hours every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Trabectidin |
|---|---|
| Age, Customized 40-49 years | 3 Participants |
| Age, Customized <40 years | 1 Participants |
| Age, Customized 50-59 years | 5 Participants |
| Age, Customized 60-69 years | 7 Participants |
| Age, Customized 70-79 years | 3 Participants |
| Age, Customized >79 years | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Sex: Female, Male Female | 20 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 | 20 / 20 |
| serious Total, serious adverse events | 4 / 20 |
Outcome results
Primary
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Time frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Population: Eligible and treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Thrombocytopenia | 13 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Peripheral neuropathy | 18 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neutropenia | 2 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Coagulation | 19 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Alkaline Phosphatase | 19 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurotoxicity | 16 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 8 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Musculoskeletal | 15 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 18 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Ocular | 16 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 15 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Anemia | 3 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Fatigue | 5 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Nausea | 3 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 17 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Flu-like syndrome | 19 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vomiting | 7 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 17 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Bilirubin | 19 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Renal | 19 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Leukopenia | 2 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 14 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 8 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | ALT | 9 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other hematologic | 18 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 19 participants |
| Trabectidin | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 16 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 4 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Alkaline Phosphatase | 1 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 5 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 4 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 0 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 4 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 0 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Ocular | 3 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neutropenia | 0 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Flu-like syndrome | 0 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Renal | 1 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Anemia | 10 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Peripheral neuropathy | 2 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other hematologic | 0 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vomiting | 10 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurotoxicity | 4 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Coagulation | 1 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Musculoskeletal | 4 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 2 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Thrombocytopenia | 4 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Fatigue | 8 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Nausea | 11 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 3 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Bilirubin | 1 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 10 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | ALT | 4 participants |
| Grade 1 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Leukopenia | 0 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Coagulation | 0 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Thrombocytopenia | 0 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vomiting | 3 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Leukopenia | 7 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neutropenia | 2 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Anemia | 6 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other hematologic | 2 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 0 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Nausea | 6 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Bilirubin | 0 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | ALT | 5 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Alkaline Phosphatase | 0 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 2 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 2 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 1 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 4 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 0 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 2 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 0 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Fatigue | 7 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Musculoskeletal | 1 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurotoxicity | 0 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Peripheral neuropathy | 0 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Renal | 0 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Ocular | 1 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 0 participants |
| Grade 2 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Flu-like syndrome | 1 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Bilirubin | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Thrombocytopenia | 3 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Nausea | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Leukopenia | 10 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | ALT | 2 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Flu-like syndrome | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Fatigue | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Coagulation | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 1 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Musculoskeletal | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurotoxicity | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other hematologic | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vomiting | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Peripheral neuropathy | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Anemia | 1 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Renal | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neutropenia | 11 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 1 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Alkaline Phosphatase | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Ocular | 0 participants |
| Grade 3 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 3 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Alkaline Phosphatase | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Ocular | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurotoxicity | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Bilirubin | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Anemia | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vomiting | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | ALT | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Peripheral neuropathy | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Flu-like syndrome | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neutropenia | 5 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Nausea | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Fatigue | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Coagulation | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Renal | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Thrombocytopenia | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Musculoskeletal | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Leukopenia | 1 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other hematologic | 0 participants |
| Grade 4 (CTCAE v 3.0) | Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 0 participants |
Primary
Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
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: CT scan or MRI if used to follow lesion for measurable disease every other cycle until disease progression for up to 5 years.
Population: Eligible and treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trabectidin | Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 | Partial response | 2 participants |
| Trabectidin | Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 | Complete response | 0 participants |