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


Phase 2
18 Years
N/A
Not Enrolling
Both
Ovarian Cancer, Sarcoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Margaret von Mehren, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02295

NCT ID:

NCT00003778

Start Date:

April 1999

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Sarcoma
  • recurrent adult soft tissue sarcoma
  • stage IV uterine sarcoma
  • recurrent uterine sarcoma
  • ovarian sarcoma
  • stage IV adult soft tissue sarcoma
  • Ovarian Neoplasms
  • Sarcoma

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Colorado Cancer CenterDenver, Colorado  80262
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111