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Phase II Evaluation of Dolastatin-10 in Patients With Hormone Refractory Prostate Cancer

Phase 2
Not Enrolling
Prostate Cancer

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Trial Information

Phase II Evaluation of Dolastatin-10 in Patients With Hormone Refractory Prostate Cancer

OBJECTIVES: I. Determine the objective response rate in patients with hormone refractory
prostate cancer treated with dolastatin 10. II. Determine the toxicity of this regimen in
this patient population.

OUTLINE: Patients receive dolastatin 10 IV bolus every 3 weeks. Treatment continues for a
minimum of 2 courses in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Hormone refractory metastatic prostate cancer (stage D1 or D2)
with no greater than 3 prior endocrine manipulations PSA level increased on 3 consecutive
measurements at least 2 weeks apart PSA at least 10 ng/mL (not required if measurable

PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy:
At least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Hemoglobin at least
8 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2 mg/dL AST no
greater than 2 times upper limit of normal Renal: Creatinine less than 2.0 mg/dL Other: No
other serious medical illness No serious infection No other prior malignancy within the
past 5 years except nonmelanoma skin cancer or any in situ carcinoma

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: See Disease Characteristics Concurrent LHRH-agonist
therapy allowed without antiandrogens At least 4 weeks since prior flutamide and
nilutamide At least 6 weeks since prior bicalutamide At least 4 weeks since other prior
hormone therapy including steroids Radiotherapy: At least 4 weeks since prior radiation
therapy and recovered No prior strontium Surgery: Recovered from prior surgery

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Maha Hadi A. Hussain, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




Start Date:

October 1998

Completion Date:

May 2000

Related Keywords:

  • Prostate Cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



University of Colorado Cancer Center Denver, Colorado  80262
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111