Carboplatin Plus Docetaxel (Taxotere) in Anaplastic Prostate Cancer
This study has been completed.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: August 9, 2007
Last updated: January 16, 2014
Last verified: January 2014
The goal of this clinical research study is to learn about how effective 2 different schedules of chemotherapy drugs (Paraplatin [carboplatin] plus Taxotere [docetaxel] and VePesid [etoposide] plus Platinol-AQ [cisplatin]) are in the treatment of patients with anaplastic prostate cancer. The safety of both therapy combinations will also be studied.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Study of Carboplatin Plus Docetaxel (Taxotere) in Patients With Anaplastic Prostate Carcinoma
Primary Outcome Measures:
- Response Rate [ Time Frame: Response evaluated at end of course 1 (up to 84 days after day 1 of cycle 1) and at the end of course 2 (up to 168 days after day 1 of cycle 1). ] [ Designated as safety issue: No ]
Response evaluated at end of course 1 (up to 84 days after day 1 of cycle 1) and at the end of course 2 (up to 168 days after day 1 of cycle 1). Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response: disappearance of all target lesions. Partial Response: > 30% decrease in sum longest diameter of target lesions, reference baseline sum longest diameter; Progressive Disease: >20% increase in sum of longest diameter target lesions, reference smallest sum longest diameter recorded since treatment started or appearance of 1/> new lesions. Stable Disease: Insufficient shrinkage to qualify as partial response, or insufficient increase to qualify for progressive disease, reference smallest sum longest diameter since treatment started.
- Median Overall Survival [ Time Frame: Baseline (start of treatment) to disease progression or death for any reason, up to 5 years of follow up. ] [ Designated as safety issue: No ]
From the date of treatment to the date of death and to the date of last follow-up for those still alive. Survival updates taken at 6 month intervals from the offstudy date.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2013 (Final data collection date for primary outcome measure)
Experimental: Carboplatin + Docetaxel
Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m^2 IV over 60 minutes, Day 1 repeated every 3 weeks.
75 mg/m^2 IV Over 60 Minutes On Day 1 Repeat Every 3 Weeks.
Other Name: Taxotere
AUC = 5 IV Over 30 Minutes On Day 1 repeat every 3 weeks.
Other Name: Paraplatin
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patient must have androgen independent Stage IV prostate cancer, with anaplastic features as defined by at least one of the following: a) Histologic evidence of small cell(pure/mixed), locally advanced or metastatic; b) Any of the following at Dx: exclusive visceral mets, predominant lytic mets, bulky ( >/= 5 cm) lymphadenopathy, or bulky ( >/= 5 cm) high-grade (Gleason >/= 8) tumor mass in the prostate/pelvis c) Low PSA at Dx + high volume bone mets.
- (#1 cont'd) d) Neuroendocrine markers in histology (+ Chromogranin A and/or Synaptophysin) or serum (abnl high serum Chromogranin A or Bombesin) at Dx or at progression plus any of the following: elevated serum LDH, malignant HyperCa+, or elevated serum CEA in the absence of other etiologies. e) Short interval (< 6 months) to androgen-independent progression following initiation of hormonal therapy with or without presence of neuroendocrine markers.
- Patients with small cell carcinoma on histology are not required to have received prior androgen deprivation therapy (ADT). All other patients must have evidence of disease progression while on ADT or an unsatisfactory response to >/= 1 month of castration, as defined by lack of symptom control and/or serum tumor marker response of < 20% (confirmed by a second value drawn on a different day).
- Zubrod performance status of </= 2.
- Normal EKG or, if EKG is suggestive of cardiomyopathy, patient has a resting Left Ventricular Ejection Fraction (LEVF) >/= 50% within 4 months.
- Patient has all of the following pretreatment laboratory data within 14 days before registration: • Absolute neutrophil count (ANC) >=1,500/mm^3.(unless due to bone marrow infiltration by tumor, in which case ANC >/= 500/mm^3 are allowed). • Platelets >=100,000/mm^3 (unless due to bone marrow infiltration by tumor, in which case platelets >/= 20,000/mm^3 are allowed)
- (#7 cont'd) • Total bilirubin </= 2 mg/dl; if greater, conjugated bilirubin should be <= 1.0 mg/dL, • SGPT (ALT) and/or SGOT (AST) </= 4 x the ULN. • Creatinine clearance >/= 40 (either measured or calculated by Cockcroft formula) • Castrate levels of serum testosterone (</= 50ng/mL) if no small cell elements on histology. (If small cell, testosterone > 50ng/mL)
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of standard medical care.
- Immunotherapy or chemotherapy within four weeks (nitrosoureas within six weeks) of registration.
- 2 or more prior chemotherapy regimens (ketoconazole, aminoglutethimide or dutasteride do not count as chemotherapy for this trial).
- Prior Platinum, Etoposide, or Taxane-based therapy that was completed less than 6 months from registration.
- Samarium-153 within four weeks of registration, or Strontium-89 within 12 weeks of registration. Patients who have received 2 or more doses of bone-seeking radioisotopes are not eligible.
- Patient has not recovered from all serious toxic effects of previous chemotherapy, radiation or antibody therapy, or from previous major surgery.
- Patients with symptomatic and untreated brain metastases or central nervous system disease will be excluded. Patients with untreated, asymptomatic brain metastasis (not requiring corticosteroid treatment for control of CNS symptoms) may be eligible, at the discretion of the MDACC Principal Investigator. Patients with treated brain metastases are eligible.
- Patient with significant atherosclerotic disease, as defined by: a) myocardial infarction within six months of enrollment. Current uncontrolled/unstable angina pectoris or electrocardiographic evidence of acute ischemia b) clinically significant ventricular arrhythmias c) symptomatic congestive heart failure (NYHA Class III)
- Patient has >= Grade 2 peripheral neuropathy.
- Patient has renal insufficiency with CrCL < 40ml/min with non-correctable etiologies.
- Patient has an uncontrolled intercurrent illness (e.g., active infection).
- Patient has another serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the patient's ability to provide informed consent or with the completion of treatment according to this protocol.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00514540
|University of California-San Francisco
|San Francisco, California, United States, 94143 |
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Ana M. Aparicio, MD
||M.D. Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 9, 2007
||January 16, 2014
||United States: Institutional Review Board
Keywords provided by M.D. Anderson Cancer Center:
Anaplastic Prostate Cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Molecular Mechanisms of Pharmacological Action