Clinical trial NCT00675545: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hormone-Refractory Prostate Cancer
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2008-05-09
Enrollment: 2
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate.
2. 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.
3. Disease progression following androgen deprivation therapy.
4. Progression is defined according to the PSA Working Group criteria (see 6.1.3 and 6.3).
5. Serum testosterone levels \< 50 ng/mm3 (unless surgically castrate). Patients must continue androgen deprivation with an LHRH analogue if they have not undergone orchiectomy.
6. No use of an antiandrogen for at least 4 weeks.
7. Have not been treated with chemotherapy before.
8. ECOG performance status of \<= 2.
9. 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
10. Signed informed consent form.
11. Age: 30 years old and above

Exclusion Criteria:

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

Primary outcomes:
measure: efficacy of docetaxel plus carboplatin
timeFrame: evaluated every 3 cycles (9 weeks)
Secondary outcomes:
measure: duration of response and toxicity profile of docetaxel and carboplatin.
timeFrame: during patient's treatment
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Alvin Wong, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.