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A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients

Primary Purpose

Hormone-Refractory Prostate Cancer

Status

Completed

Phase

Phase 2

Locations

Singapore

Study Type

Interventional

Intervention

Docetaxel, Carboplatin

About this trial

This is an interventional treatment trial for Hormone-Refractory Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate.
At the time of enrollment, patients must have evidence of metastatic disease, with either measurable disease per RECIST criteria or non- measurable disease (i.e. positive bones scan) and PSA > 5 ng/mm3.
Disease progression following androgen deprivation therapy.
Progression is defined according to the PSA Working Group criteria (see 6.1.3 and 6.3).
Serum testosterone levels < 50 ng/mm3 (unless surgically castrate). Patients must continue androgen deprivation with an LHRH analogue if they have not undergone orchiectomy.
No use of an antiandrogen for at least 4 weeks.
Have not been treated with chemotherapy before.
ECOG performance status of <= 2.
Laboratory criteria for entry:
- White blood cell (WBC) => 3000/mm3
- Platelets => 100,000/mm3
- AST < 2.5 x upper limit of normal
- Calculated CCT of => 40 ml/min
Signed informed consent form.
Age: 30 years old and above

Exclusion Criteria:

Significant peripheral neuropathy defined as grade 2 or higher.
Within 4 weeks since completing external beam radiotherapy or 8 weeks since completing radiopharmaceutical therapy (strontium, samarium).
Concomitant chemotherapy or investigational agents.

Sites / Locations

National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

docetaxel and prednisolone

Arm Description

Patients in study will receive both chemotherapeutic agents on day 1 and day 8 of every 21-day cycle as described below: Docetaxel 30 mg/m2 over 1 hour IV infusion, followed by Carboplatin (AUC 2) over 1 hour IV infusion Additonal medication required: IV Dexamethasone 10 mg followed by PO dexamethasone 4 mg 8 hourly x 4 doses, starting 12 hours after starting iv docetaxel.

Outcomes

Primary Outcome Measures

efficacy of docetaxel plus carboplatin

The primary endpoint of the study is best overall response (complete or partial response) obtained from measurable target lesion or PSA, as defined using the modified RECIST criteria.

Secondary Outcome Measures

duration of response and toxicity profile of docetaxel and carboplatin.

Full Information

NCT ID

NCT00675545

First Posted

May 7, 2008

Last Updated

March 30, 2012

Sponsor

National University Hospital, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT00675545

Brief Title

A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients

Official Title

A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National University Hospital, Singapore

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective is to determine the efficacy of docetaxel plus carboplatin as first line treatment in patients with hormone refractory prostate cancer.

Detailed Description

Docetaxel-prednisolone is the current standard in HRPC, based on 2 large randomized trials showing improved survival compared to mitoxantrone-prednisolone. Carboplatin has activity in prostate cancer and the combination of Docetaxel-carboplatin is known to be synergistic and is used with good effect in many cancers. The advantage of using this combination in prostate cancer is suported by clinical data: high response rates of docetaxel-carboplatin-estramustine (with G-CSF support) in a phase II trial (Oh, Halabi, Kelly et al. Cancer. 2003 Dec 15;98(12):2592-8), and additional effect of this combination in prior taxane failures (Oh, George, Tay. Clin Prostate Cancer. 2005 Jun;4(1):61-4). Carboplatin itself has activity and theoretically could target the more hormone resistant clones or neuroendocrine components of the tumor.(Di Sant' Agnese. J Urol. 1994 Nov;152(5 Pt 2):1927-31.) We are studying the combination of docetaxel-carboplatin both given in a weekly, low-dose fashion, without estramustine and without G-CSF. This is expected to be an effective and tolerable treatment for HRPC patients. We will be documenting (to our knowledge) for the first time in this trial the efficacy of the combination given in this particular dose and schedule.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hormone-Refractory Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

docetaxel and prednisolone

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Docetaxel, Carboplatin

Other Intervention Name(s)

Carboplatin (Paraplatin), Docetaxel (Taxotere®)

Intervention Description

Docetaxel Form: A white, lyophilized powder in vials of 50, 150, and 450 mg each, which should be stored at room temperature in a light-protected area. Carboplatin Form: Taxotere is supplied as a sterile, non-aqueous, viscous solution with an accompanying sterile diluent (13% ethanol in water for injection). 20 and 80 mg strengths are available.

Primary Outcome Measure Information:

Title

efficacy of docetaxel plus carboplatin

Description

The primary endpoint of the study is best overall response (complete or partial response) obtained from measurable target lesion or PSA, as defined using the modified RECIST criteria.

Time Frame

evaluated every 3 cycles (9 weeks)

Secondary Outcome Measure Information:

Title

duration of response and toxicity profile of docetaxel and carboplatin.

Time Frame

during patient's treatment

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate. At the time of enrollment, patients must have evidence of metastatic disease, with either measurable disease per RECIST criteria or non- measurable disease (i.e. positive bones scan) and PSA > 5 ng/mm3. Disease progression following androgen deprivation therapy. Progression is defined according to the PSA Working Group criteria (see 6.1.3 and 6.3). Serum testosterone levels < 50 ng/mm3 (unless surgically castrate). Patients must continue androgen deprivation with an LHRH analogue if they have not undergone orchiectomy. No use of an antiandrogen for at least 4 weeks. Have not been treated with chemotherapy before. ECOG performance status of <= 2. Laboratory criteria for entry: White blood cell (WBC) => 3000/mm3 Platelets => 100,000/mm3 AST < 2.5 x upper limit of normal Calculated CCT of => 40 ml/min Signed informed consent form. Age: 30 years old and above Exclusion Criteria: Significant peripheral neuropathy defined as grade 2 or higher. Within 4 weeks since completing external beam radiotherapy or 8 weeks since completing radiopharmaceutical therapy (strontium, samarium). Concomitant chemotherapy or investigational agents.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alvin Wong, MD

Organizational Affiliation

National University Hospital, Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

National University Hospital

City

Singapore

Country

Singapore

12. IPD Sharing Statement

Citations:

PubMed Identifier

15470213

Citation

Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.

Results Reference

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PubMed Identifier

14669278

Citation

Oh WK, Halabi S, Kelly WK, Werner C, Godley PA, Vogelzang NJ, Small EJ; Cancer and Leukemia Group B 99813. A phase II study of estramustine, docetaxel, and carboplatin with granulocyte-colony-stimulating factor support in patients with hormone-refractory prostate carcinoma: Cancer and Leukemia Group B 99813. Cancer. 2003 Dec 15;98(12):2592-8. doi: 10.1002/cncr.11829.

Results Reference

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A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients

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