NCT Number: NCT00003626
Dolastatin 10 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Previous Hormone Therapy
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with metastatic prostate cancer that has not responded to previous hormone therapy.
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Notify MeKey information
Conditions
Sex eligibility
Male
Study type
Interventional
Phase
Phase 2
Primary location
University of Colorado Cancer Center, Denver, Colorado, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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 disease)
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
Treatment and study plan
Sponsors and collaborators
Lead sponsor
Barbara Ann Karmanos Cancer Institute
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Phase II Evaluation of Dolastatin-10 in Patients With Hormone Refractory Prostate Cancer
Important dates
- Study start
- 1998
- Primary completion
- 1999
- Study completion
- 2000
- First posted
- Aug 17, 2004
- Registry last updated
- Apr 5, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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