Dolastatin 10 in Treating Patients With Recurrent or Metastatic Soft Tissue Sarcoma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00003778 |
Recruitment Status
:
Completed
First Posted
: August 27, 2004
Last Update Posted
: February 8, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Cancer Sarcoma | Drug: dolastatin 10 | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of Dolastatin-10 in Patients With Previously Untreated Recurrent/Metastatic Sarcoma |
Study Start Date : | April 1999 |
Actual Primary Completion Date : | July 2000 |

Arm | Intervention/treatment |
---|---|
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 |

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003778
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 |
Study Chair: | Margaret von Mehren, MD | Fox Chase Cancer Center |
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 ( Registry Identifier: PDQ (Physician Data Query) ) |
First Posted: | August 27, 2004 Key Record Dates |
Last Update Posted: | February 8, 2013 |
Last Verified: | September 2000 |
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:
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Dolastatin 10 |
Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |