Dolastatin 10 in Treating Patients With Recurrent or Metastatic Soft Tissue Sarcoma

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Sarcoma

Ovarian Cancer

Treatments

Drug: dolastatin 10

Study type

Interventional

Funder types

NIH

Identifiers

NCT00003778

CDR0000066907 (Registry Identifier)

FCCC-98019

NCI-2012-02295

NCI-T98-0026

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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