Ovarian Cancer, Sarcoma
Conditions
Keywords
recurrent adult soft tissue sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, ovarian sarcoma, stage IV adult soft tissue sarcoma
Brief summary
Phase II trial to study the effectiveness of dolastatin 10 in treating patients who have recurrent or metastatic soft tissue sarcoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed description
OBJECTIVES: I. Determine the response rate in patients with recurrent or metastatic soft tissue sarcomas treated with dolastatin 10. II. Determine the toxicity of this regimen in this patient population. OUTLINE: This is an open label, multicenter study. Patients are stratified according to center, prior therapy, histologic subtype, stage of disease at diagnosis, and current status of disease (recurrent vs metastatic). Patients receive dolastatin 10 IV over 10 minutes. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month.
Interventions
DRUGdolastatin 10
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically proven recurrent or metastatic soft tissue sarcoma * No rhabdomyosarcoma, Ewing's sarcoma, chondrosarcoma, osteogenic sarcoma, mesothelioma, or Kaposi's sarcoma Bidimensionally measurable disease other than previously irradiated disease site(s) even if there has been progression within the radiation field * Pulmonary nodule(s) at least 1 x 1 cm No brain metastases PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: ECOG 0 or 1 * Absolute neutrophil count at least 2,000/mm3 * Platelet count at least 100,000/mm3 * Bilirubin no greater than 1.5 mg/dL * AST and ALT less than 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases present) * Creatinine no greater than 1.5 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study * No uncontrolled infection * No history of prior malignancy within the past 5 years except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other malignancy in complete remission PRIOR CONCURRENT THERAPY: * No more than 1 prior chemotherapy regimen in the adjuvant setting * No prior chemotherapy for metastatic disease * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) * At least 4 weeks since prior radiotherapy * Recovered from prior surgery
Countries
United States
Outcome results
None listed