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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003778
First received: November 1, 1999
Last updated: February 7, 2013
Last verified: September 2000
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Sarcoma
Drug: dolastatin 10
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Dolastatin-10 in Patients With Previously Untreated Recurrent/Metastatic Sarcoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Enrollment: 37
Study Start Date: April 1999
Primary Completion Date: July 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003778

Locations
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80262
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Investigators
Study Chair: Margaret von Mehren, MD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003778     History of Changes
Other Study ID Numbers: NCI-2012-02295, FCCC-98019, NCI-T98-0026, CDR0000066907
Study First Received: November 1, 1999
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent adult soft tissue sarcoma
stage IV uterine sarcoma
recurrent uterine sarcoma
ovarian sarcoma
stage IV adult soft tissue sarcoma

Additional relevant MeSH terms:
Ovarian Neoplasms
Sarcoma
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Dolastatin 10
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014