search
Back to results

Chemotherapy in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
exatecan mesylate
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage IV prostate cancer, recurrent prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed prostate carcinoma Metastatic disease Documented progression of prostate cancer while receiving androgen ablative therapy (i.e., surgical or chemical castration and a serum testosterone level in the castrate range) Documented hormone therapy resistance defined as: PSA rise on 3 occasions not less than 4 weeks apart Any evidence of progressive measurable disease PSA must be above 20 ng/mL prior to study entry No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hemoglobin at least 9.0 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT/SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled angina No myocardial infarction within the past 6 months Other: Fertile patients must use effective contraception No uncontrolled pain requiring irradiation No concurrent serious infection No other malignancy within the past 5 years except nonmelanoma skin cancer No overt psychosis, mental disability, or incompetence PRIOR CONCURRENT THERAPY: Biologic therapy: No prophylactic colony stimulating factors to prevent neutropenia No concurrent biologic therapy Chemotherapy: No more than 1 prior cytotoxic chemotherapy regimen No concurrent cytotoxic chemotherapy Endocrine therapy: See Disease Characteristics At least 6 weeks since prior peripheral antiandrogens (e.g., flutamide) No concurrent steroid therapy initiated within past 2 months Current LHRH agonist therapy should continue through study Radiotherapy: At least 4 weeks since prior radiotherapy (except low dose, non myelosuppressive) and recovered No prior irradiation to greater than 25% of bone marrow No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior major surgery and recovered No concurrent surgery Other: No other concurrent anticancer treatment At least 28 days since investigational drugs, including analgesics or antiemetics No other investigational drugs during and for 28 days after study No concurrent drugs that induce or inhibit CYP3A enzyme No concurrent herbal preparations (e.g., PC-SPES)

Sites / Locations

  • U.S. Oncology Research Inc.
  • Institute for Drug Development

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 10, 1999
Last Updated
May 15, 2012
Sponsor
Daiichi Sankyo, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00004045
Brief Title
Chemotherapy in Treating Patients With Prostate Cancer
Official Title
A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Hormone-Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 1999 (undefined)
Primary Completion Date
August 2001 (Actual)
Study Completion Date
August 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

5. Study Description

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 DX-8951f in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Detailed Description
OBJECTIVES: I. Determine the antitumor activity of DX-8951f as measured by PSA response in patients with hormone refractory prostate cancer. II. Determine the antitumor activity of this drug in the subpopulation of these patients with measurable disease. III. Evaluate the quantitative and qualitative toxicities of this drug in these patients. IV. Evaluate the pharmacokinetics of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients with no evidence of PSA decrease by the start of course 3 receive no further treatment. Patients are followed every 3 months until death. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage IV prostate cancer, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
exatecan mesylate

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed prostate carcinoma Metastatic disease Documented progression of prostate cancer while receiving androgen ablative therapy (i.e., surgical or chemical castration and a serum testosterone level in the castrate range) Documented hormone therapy resistance defined as: PSA rise on 3 occasions not less than 4 weeks apart Any evidence of progressive measurable disease PSA must be above 20 ng/mL prior to study entry No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hemoglobin at least 9.0 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT/SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled angina No myocardial infarction within the past 6 months Other: Fertile patients must use effective contraception No uncontrolled pain requiring irradiation No concurrent serious infection No other malignancy within the past 5 years except nonmelanoma skin cancer No overt psychosis, mental disability, or incompetence PRIOR CONCURRENT THERAPY: Biologic therapy: No prophylactic colony stimulating factors to prevent neutropenia No concurrent biologic therapy Chemotherapy: No more than 1 prior cytotoxic chemotherapy regimen No concurrent cytotoxic chemotherapy Endocrine therapy: See Disease Characteristics At least 6 weeks since prior peripheral antiandrogens (e.g., flutamide) No concurrent steroid therapy initiated within past 2 months Current LHRH agonist therapy should continue through study Radiotherapy: At least 4 weeks since prior radiotherapy (except low dose, non myelosuppressive) and recovered No prior irradiation to greater than 25% of bone marrow No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior major surgery and recovered No concurrent surgery Other: No other concurrent anticancer treatment At least 28 days since investigational drugs, including analgesics or antiemetics No other investigational drugs during and for 28 days after study No concurrent drugs that induce or inhibit CYP3A enzyme No concurrent herbal preparations (e.g., PC-SPES)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L. DeJager, MD, FACP
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
U.S. Oncology Research Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77060
Country
United States
Facility Name
Institute for Drug Development
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78245-3217
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Chemotherapy in Treating Patients With Prostate Cancer

We'll reach out to this number within 24 hrs