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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003778
• Other study ID #: NCI-2012-02295
• Secondary ID: FCCC-98019NCI-T9
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: February 7, 2013
• Start date: April 1999

Study information

• Verified date: September 2000
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. primary completion date: July 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Sarcoma

Intervention

Drug:
• dolastatin 10

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Mayo Clinic Cancer Center	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,