MDACC Study Summary 2006-0097

Study Summary
No. 2006-0097:.......Genitourinary......Ana M. Aparicio......Genitourinary Medical Oncology

Study Summary Title



Study Summary Number:	2006-0097

Study Title:	Phase II Study of Carboplatin Plus Docetaxel in Patients with Anaplastic Prostate Carcinoma.

Physician

New Patient Referral



Name:	Ana M. Aparicio	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Genitourinary Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2830 Contact us about clinical trials

General Information



Disease Group:	Genitourinary	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Before each cycle of treatment(every 3-4 weeks). Patients will be seen at MDACC to determine continuation of therapy every 2 courses.

Treatment Agents:	Carboplatin Cisplatin Etoposide Taxotere	Home Care:	Patients may have interim labs at home. Scans may be done at home if adequate copies are provided. Chemotherapy can be given at MDACC or with local MD.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Patients will be seen weekly for blood counts. Chemotherapy stay will be 1-3 days depending on individual patient tolerance.


Description/ Intervention:	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.

Study Objectives / Outcomes

Primary Objectives:

1. To estimate the response rate and time to progression (TTP) for patients with anaplastic prostate carcinoma treated with docetaxel and carboplatin.

2. To estimate the response rate and TTP of salvage chemotherapy with etoposide plus cisplatin following treatment with carboplatin and docetaxel.

Secondary Objectives:

1. To define the clinical characteristics of patients whose cancer has a favorable response to carboplatin/docetaxel versus etoposide/cisplatin therapies

2. To evaluate toxicity of carboplatin and docetaxel as initial therapy in this population.

3. To evaluate toxicity of salvage chemotherapy with etoposide and cisplatin following therapy carboplatin and docetaxel.

4. To estimate the overall survival of patients with anaplastic prostate carcinoma treated with the treatment algorithm of initial carboplatin plus docetaxel followed by selective use of etoposide and cisplatin

5. To collect tissue for hypothesis generating interrogation of tissue that may lead to insight into the underlying biology of "anaplastic" cancers of the prostate.

Other Objective(s) - Correlative studies
1. Assessment of testosterone and DHT in serum plasma and bone marrow aspirate will be performed in collaboration with Dr Peter S Nelson.

2. Pathology review of Bone marrow biopsies will be performed by Dr Patricia Troncoso

3. Additional serum and plasma as well as bone marrow aspirate will be collected and stored in the Genitourinary Biorepository for further studies

Study Status Information



Study Activation / Registration Date:	05/10/2006

IRB Review and Approval Date:	03/15/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	120

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) 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.

2) (#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.

3) 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).

4) Zubrod performance status of </= 2.

5) Normal EKG or, if EKG is suggestive of cardiomyopathy, patient has a resting Left Ventricular Ejection Fraction (LEVF) >/= 50% within 4 months.

6) 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) (#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)

8) Patient has given voluntary written informed consent before performance of any study-related procedure not part of standard medical care.

Exclusion Criteria:

1) Immunotherapy or chemotherapy within four weeks (nitrosoureas within six weeks) of registration.

2) 2 or more prior chemotherapy regimens (ketoconazole, aminoglutethimide or dutasteride do not count as chemotherapy for this trial).

3) Prior Platinum, Etoposide, or Taxane-based therapy that was completed less than 6 months from registration.

4) 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.

5) Patient has not recovered from all serious toxic effects of previous chemotherapy, radiation or antibody therapy, or from previous major surgery.

6) 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.

7) 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)

8) Patient has >= Grade 2 peripheral neuropathy.

9) Patient has renal insufficiency with CrCL < 40ml/min with non-correctable etiologies.

10) Patient has an uncontrolled intercurrent illness (e.g., active infection).

11) 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.

Links

Registration Number: NCT00514540
Study Information on Clinical Trials Registry (clinicaltrials.gov)