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Home > "M" Clinical Trials Conditions > MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy  MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
For Condition: recurrent prostate cancer,adenocarcinoma of the prostate
Status: No longer recruiting
Sponsor(s): EORTC New Drug Development Group ,
Synopsis: 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 MEN-10755 in treating patients who have progressive prostate cancer that has not responded to hormone therapy.
Details: OBJECTIVES: - Assess the activity of MEN-10755 in patients with progressive hormone-refractory adenocarcinoma of the prostate. - Determine the rate and duration of objective PSA response in patients treated with this drug. - Determine the clinical response rate in patients with measurable disease treated with this drug. - Determine the acute side effects of this drug in these patients. OUTLINE: This is a multicenter study. Beginning within 2 weeks after the last PSA measurement, patients receive MEN-10755 IV over 30 minutes on day 1. Treatment repeats every 3 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete or partial response continue to receive additional courses. Patients who achieve stable disease may receive more than 4 courses at the discretion of the investigator. Patients are followed every 6 weeks until disease progression or initiation of a new therapy. PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed hormone-refractory adenocarcinoma of the prostate - Disease progression while on prior luteinizing hormone-releasing hormone (LHRH) analogues or after orchiectomy and antiandrogens, given concurrently or consecutively - Disease progression is defined as PSA progression documented by increases in PSA recorded at 2 consecutive measurements over a prior reference value - Interval of at least 1 week between the reference value and the first of these two PSA increases - Continued elevation of PSA for at least 6 weeks after discontinuation of antiandrogens - Last PSA value at least 5 ng/mL (Hybritech equivalent) - Must have serum testosterone less than 50 ng/mL and must continue on LHRH agonist therapy if no prior surgical castration - No symptomatic brain or leptomeningeal metastatic disease PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - ALT/AST no greater than 2.5 times ULN (5 times ULN if liver metastases present) Renal: - Creatinine no greater than 1.7 mg/dL - No uncontrolled hypercalcemia Cardiovascular: - No history of severe heart disease - No myocardial infarction within the past 6 months - No cardiac insufficiency - Normal cardiac function by MUGA scan and 12-lead EKG Other: - No other prior or concurrent malignancy except basal cell or squamous cell skin cancer - No uncontrolled systemic nonmalignant disease or infection - No psychological, familial, or geographical conditions that would preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 4 weeks since prior chemotherapy Endocrine therapy: - See Disease Characteristics - No prior hormonal therapy except estramustine - No concurrent estramustine Radiotherapy: - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy (e.g., for painful bone metastases) Surgery: - See Disease Characteristics Other: - No other concurrent experimental drugs or investigational therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WalterFiedler, Study Chair, Universitaets-Krankenhaus Eppendorf
Institut Bergonie
Bordeaux, , 33076
France
Centre Jean Perrin
Clermont-Ferrand, , 63011
France
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
CHU Pitie-Salpetriere
Paris, , 75651
France
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Dijon, , 21079
France
Rabin Medical Center - Beilinson Campus
Petah-Tikva, , 49100
Israel
CHU de la Timone
Marseille, , 13385
France
Universitaets-Krankenhaus Eppendorf
Hamburg, , D-20246
Germany
Hospital Universitario 12 de Octubre
Madrid, , 28041
Spain
Inselspital, Bern
BERN, , CH-3010
Switzerland
Additional Information:
Study ID Numbers: CDR0000069067; MAC-07,EORTC-16006-30005
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027781
Other Recurrent Prostate Cancer Studies:
1. Monoclonal Antibody and Sargramostim in Treating Patients With Metastatic Prostate Cancer
2. Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
3. Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate
4. Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer
5. Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors
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MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
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