Dolastatin 10 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Previous Hormone Therapy

NCT ID: NCT00003626

Last Updated: 2013-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-10-31
• Study Completion Date: 2000-05-31

Brief Summary

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.

Detailed Description

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.

Conditions

Prostate Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

dolastatin 10

Intervention Type: DRUG

Eligibility Criteria

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 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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maha Hadi A. Hussain, MD

Role: STUDY_CHAIR

Barbara Ann Karmanos Cancer Institute

Locations

University of Colorado Cancer Center

Denver, Colorado, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

References

Vaishampayan U, Glode M, Du W, Kraft A, Hudes G, Wright J, Hussain M. Phase II study of dolastatin-10 in patients with hormone-refractory metastatic prostate adenocarcinoma. Clin Cancer Res. 2000 Nov;6(11):4205-8.

Reference Type: RESULT

PMID: 11106233 (View on PubMed)

Other Identifiers

P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-D-1644

Identifier Type: -

Identifier Source: secondary_id

NCI-T98-0019

Identifier Type: -

Identifier Source: secondary_id

CDR0000066708

Identifier Type: -

Identifier Source: org_study_id