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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Trial of Dolastatin-10 in Patients With Previously Untreated Recurrent/Metastatic Sarcoma

Conditions
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Sarcoma, Ovarian Cancer

Intervention / Treatment
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* Drug: dolastatin 10


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive dolastatin 10 IV over 10 minutes. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. | Drug: dolastatin 10<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult soft tissue sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, ovarian sarcoma, stage IV adult soft tissue sarcoma