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

Primary Purpose

Ovarian Cancer, Sarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dolastatin 10
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent adult soft tissue sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, ovarian sarcoma, stage IV adult soft tissue sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Cancer Center
  • Mayo Clinic Cancer Center
  • Arthur G. James Cancer Hospital - Ohio State University
  • Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

Patients receive dolastatin 10 IV over 10 minutes. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
February 7, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003778
Brief Title
Dolastatin 10 in Treating Patients With Recurrent or Metastatic Soft Tissue Sarcoma
Official Title
Phase II Trial of Dolastatin-10 in Patients With Previously Untreated Recurrent/Metastatic Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2000
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
July 2000 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Sarcoma
Keywords
recurrent adult soft tissue sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, ovarian sarcoma, stage IV adult soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive dolastatin 10 IV over 10 minutes. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
dolastatin 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret von Mehren, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States

12. IPD Sharing Statement

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

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