MDACC Study Summary 2006-0840

Study Summary
No. 2006-0840:.......Prostate......John Araujo......Genitourinary Medical Oncology

Study Summary Title



Study Summary Number:	2006-0840

Study Title:	A Phase I/II Trial of ABI-008 (nab-docetaxel) in Patients with Hormone-refractory Prostate Cancer

Physician

New Patient Referral



Name:	John Araujo	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:	Prostate	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	Participants will return weekly for laboratory testing and receive treatment every 3 weeks.

Treatment Agents:	ABI-008 Prednisone	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A

Description/
Intervention:

The goal of this clinical research study is to find the highest tolerable dose
of ABI-008 when given in combination with prednisone that can be given to
patients with prostate cancer that has spread to other organs.

Researchers will also look at the pharmacokinetics (PK) of ABI-008. PK testing
is done to learn how a drug acts in the body over time, including how it is
absorbed into the body, how it moves throughout the body, and how the body gets
rid of it.

Study Objectives / Outcomes

Primary Objectives:

The primary objectives of this study are to establish the maximum tolerated dose (MTD)
of ABI-008 in the presence of prednisone and to determine the dose-limiting toxicities (DLTs) of ABI-008 given every 3 weeks plus prednisone 5 mg given orally twice daily; to characterize the toxicities of ABI-008 in combination with prednisone; and to determine the pharmacokinetic parameters for ABI-008 when given on an every-3-week schedule plus prednisone 5 mg given orally twice daily.

Secondary Objective:

Report the efficacy of ABI-008 plus prednisone 5 mg given orally twice daily in this patient population.

Study Status Information



Study Activation / Registration Date:	04/04/2007

IRB Review and Approval Date:	01/26/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	53

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) Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate that is clinically refractory to hormone therapy.

2) Zubrod Performance Status 0-1.

3) At the time of enrollment, patients must have evidence of progressive metastatic disease, either: • Measurable disease with any level of serum PSA OR • Non-measurable disease with PSA >/= 5 ng/ml. Patients with PSA >/= 5 ng/ml only and no other radiographic evidence of metastatic prostate cancer are not eligible.

4) Patients must have demonstrated evidence of progressive disease since the most recent change in therapy. Progressive disease is defined as any one of the following (measurable disease, bone scan, or PSA progression): 1)Measurable Disease Progression: Objective evidence of increase >20% in the sum of the longest diameters (LD) of target lesions from the time of maximal regression or the appearance of one or more new lesions.

5) (Inclusion # 4 cont'd) 2)Bone Scan Progression: Appearance of either of the following will constitute progression: (a) 2 or more new lesions on bone scan attributable to prostate cancer; or (b) one new lesion on bone scan attributable to prostate cancer in conjunction with a rising PSA. 3)PSA Progression: In the presence of radiographic evidence of disease, an elevated PSA (>/=5 ng/mL) which has risen serially from BL on two occasions each at least 1 week apart. If the confirmatory PSA value is < screening PSA value, an additional test for rising PSA will be required to document progression.

6) Serum testosterone </= 50 ng/ml, determined within two weeks prior to starting treatment.

7) Maintaining castrate status: Patients who have not undergone surgical orchiectomy should continue on medical therapies [e.g. gonadotropin releasing hormone analogs (GnRH analogs)] to maintain castrate levels of serum testosterone. Patients who are receiving an anti-androgen as part of their first-line hormonal therapy must have shown progression of disease off of the anti-androgen prior to enrollment (6 weeks withdrawal for Casodex; 4 weeks for flutamide).

8) Megestrol acetate (Megace�) treatment may continue if patient has been on stable doses of the drug. If patients discontinue Megace, they must show progression of disease off of this medication.

9) Age > 18 years of age.

10) Four weeks since major surgery.

11) The following restrictions on prior therapy for metastatic disease apply: - No prior chemotherapy regimen for metastatic disease. - No more than one prior course of palliative radiotherapy. - Up to one prior treatment with a non-chemotherapeutic agent (e.g., kinase inhibitors, immunotherapeutic agents, etc) is permitted as treatment for metastatic disease. - No prior radioisotope therapy with Strontium-89, Samarium or similar agents. - One prior neo-adjuvant or adjuvant chemotherapy regimen is permitted if given over 3 years ago.

12) No limitation on prior hormonal therapy.

13) Patients should be off all therapy for at least 4 weeks prior to study drug administration.

14) Life expectancy should be >/= 3 months.

15) Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment.

16) Required Initial Laboratory Data: WBC >/= 3,000/microliters; ANC >/= 1,500/microliters; Platelet count >/= 100,000/microliters; Creatinine </= 1.5 x upper limits of normal; Bilirubin </= upper limit of normal (exceptions will be made for patients with Gilbert's Disease); SGOT (AST) </= 1.5 x upper limits of normal; SGPT (ALT) </= 1.5 x upper limits of normal

17) Taxanes are considered to be teratogenic. For this reason men whose sexual partners are of child-bearing age must agree to use adequate contraception (hormonal or barrier method of birth control) for the duration of study participation. Should a patient's sexual partner become pregnant or suspect she is pregnant while patient is participating in this study, he should inform the treating physician immediately.

18) If obese (weight > 20% of ideal body weight) patient must be treated with doses calculated using adjusted BSA (based on calculated adjusted weight) or actual BSA according to physician discretion.

Exclusion Criteria:

1) Patients may not be receiving any other investigational agents.

2) Patients may continue on a daily Multi-Vitamin, low dose (</= 400 IU qd) Vitamin D, Calcitrol (</= 0.5 mcg qd), and calcium supplements, but all other herbal, alternative and food supplements (i.e. PC-Spes, Saw Palmetto, St John Wort, etc.) must be discontinued before start of treatment.

3) Patients on stable doses of bisphosphonates, who develop subsequent tumor progression, may continue on this medication. However patients are not allowed to initiate bisphosphonate therapy immediately prior to or during the study because starting bisphosphonates would potentially confound the interpretation of adverse events.

4) Patients with known brain metastases should be excluded from this clinical trial because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.

5) Patients with history of allergic reactions attributed to solvent-based docetaxel (Taxotere) will not be eligible for the study.

6) Patients with significant cardiovascular disease including congestive heart failure (New York Heart Association Class III or IV), active angina pectoris or recent myocardial infarction (within the last 6 months) are excluded.

7) Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not to be registered. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are now considered (by their physician) to be at low risk for relapse.

8) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

9) Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with docetaxel. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.

Links

Registration Number: NCT00477529
Study Information on Clinical Trials Registry (clinicaltrials.gov)