NCT00003778

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2 ovarian-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2000

Completed
4.2 years until next milestone

First Posted

Study publicly available on registry

August 27, 2004

Completed
Last Updated

February 8, 2013

Status Verified

September 1, 2000

Enrollment Period

1.3 years

First QC Date

November 1, 1999

Last Update Submit

February 7, 2013

Conditions

Ovarian CancerSarcoma

Keywords

recurrent adult soft tissue sarcomastage IV uterine sarcomarecurrent uterine sarcomaovarian sarcomastage IV adult soft tissue sarcoma

Study Arms (1)

Arm I

EXPERIMENTAL

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

Interventions

dolastatin 10DRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

University of Colorado Cancer Center

Denver, Colorado, 80262, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsSarcoma

Interventions

dolastatin 10

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Study Officials

  • Margaret von Mehren, MD

    Fox Chase Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 27, 2004

Study Start

April 1, 1999

Primary Completion

July 1, 2000

Last Updated

February 8, 2013

Record last verified: 2000-09

Locations

US(4)