A Study of Picoplatin and Docetaxel in Subjects With Prostate Cancer

NCT00448734 | Unknown Phase 1 DMC

• 1 other identifier: 0502
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 11

Brief Summary

This study will review the safety of picoplatin, a new type of platinum drug, with docetaxel, a drug commonly used in the treatment of prostate cancer. Patients who are eligible for this study will have had a diagnosis of hormone-refractory prostate cancer that has metastasized to other areas of the body, and have not been previously treated with chemotherapy drugs. Picoplatin will be administered in combination with docetaxel and prednisone to identify the maximum tolerated dose (MTD). Patients will receive IV treatments of picoplatin with docetaxel every 3 weeks, with prednisone, 5 mg orally, twice daily.

Conditions

Hormone Refractory Prostate Cancer

Keywords

metastatic; hormone-refractory; prostate cancer; picoplatin; platinum drug; chemotherapy; docetaxel

Outcome Measures

Primary Outcomes (2)

• In Part 1, the Maximum Tolerated Dose (MTD) will be determined

  MTD

• In Part 2, PSA response will be measured (reduction of at least 50% of PSA from baseline, with reduction maintained for at least 4 weeks)

  response

Secondary Outcomes (1)

• Progression free survival

  progression

Study Arms (2)

1

EXPERIMENTAL

The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued. Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion.

Drug: Picoplatin

2

ACTIVE COMPARATOR

Docetaxel

Drug: docetaxel

Interventions

Picoplatin DRUG

The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued. Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion.

1

docetaxel DRUG

The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued. Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the prostate.
• Radiologic evidence of metastatic disease (Jewett-Whitmore Stages D1-D2 or TNM Stage N1-3 or M1).
• Disease progression or recurrence documented by either: increasing serum PSA on three consecutive measurements each obtained at least one week apart, or findings on radiographic imaging studies.
• Non-surgically castrate subjects must be receiving androgen ablation therapy as maintenance therapy.
• Adequate hormonal therapy as documented by a castrate level of serum testosterone (all subjects without surgical castration must have a serum testosterone less than 50 ng/ml).
• At least 4 weeks must have elapsed after the withdrawal of antiandrogens (6 weeks in the case of bicalutamide).
• Age 18 years and over. Subjects older than 80 years should be entered on study only if considered "physiologically appropriate" for combination chemotherapy.
• ECOG performance score (PS) of 0 or 1.
• Stable levels of pain for at least 7 days before study entry.
• Life expectancy more than 3 months.
• At least 28 days must have elapsed since prior radiotherapy.
• At least 28 days must have elapsed since any prior investigational agent.
• Absolute neutrophil count (ANC) at least 1.5 x 10\^9th/L.
• Platelet count at least 100 x 10\^9th/L.
• Hemoglobin at least 10 g/dL.

You may not qualify if:

• Prior treatment with cytotoxic agents (except estramustine), radioisotopes, or biological therapies other than hormones.
• Clinical evidence of brain or leptomeningeal metastases.
• Symptomatic peripheral neuropathy of Grade 2 or higher.
• History of another cancer within the preceding 5 years, except for superficial skin cancers.
• Known hypersensitivity to drugs formulated with Polysorbate 80.
• Prior radiotherapy that included ≥ 30% of the bone marrow (e.g., the whole of the pelvis or half of the spine).
• Uncontrolled intercurrent illness (e.g., active infection).
• Serious medical or psychiatric illness that could potentially interfere with the completion of the study treatment according to this protocol.
• History of serious cardiac disease, defined as myocardial infarction within six months of enrollment, congestive heart failure classified by the New York Heart Association as Class III or IV, uncontrolled cardiac arrhythmias, poorly controlled or unstable angina, or electrocardiographic evidence of acute ischemia.

Sponsors & Collaborators

• Poniard Pharmaceuticals: lead

Study Sites (11)

Medical Radiology Research Center under the Russian Academy of Medical Sciences

Obninsk, Kaluga Oblast, 249036, Russia

Location

Chelyabinsk Regional Oncology Center

Chelyabinsk, 454087, Russia

Location

Burdenko Central Military Clinical Hospital

Moscow, 105229, Russia

Location

Russian Research Center of Radiology

Moscow, 117997, Russia

Location

Research Institute of Urology - Ministry of Health

Moscow, Russia

Location

Leningrad Regional Oncology Center

Saint Petersburg, 188663, Russia

Location

Central Medical Unit #122

Saint Petersburg, 194291, Russia

Location

Therapeutic and Research Medical Center

Saint Petersburg, 194354, Russia

Location

St. Petersburg City Hospital #26

Saint Petersburg, 196247, Russia

Location

St. Petersburg City Oncology Center

Saint Petersburg, 198255, Russia

Location

State Medical Institution of Yaroslavl Region / Regional Clinical Oncology Hospital

Yaroslavl, 150054, Russia

Location

Related Publications (7)

• Beale P, Judson I, O'Donnell A, Trigo J, Rees C, Raynaud F, Turner A, Simmons L, Etterley L. A Phase I clinical and pharmacological study of cis-diamminedichloro(2-methylpyridine) platinum II (AMD473). Br J Cancer. 2003 Apr 7;88(7):1128-34. doi: 10.1038/sj.bjc.6600854.

  PMID: 12671715 BACKGROUND

• Canobbio L, Guarneri D, Miglietta L, Decensi A, Oneto F, Boccardo F. Carboplatin in advanced hormone refractory prostatic cancer patients. Eur J Cancer. 1993;29A(15):2094-6. doi: 10.1016/0959-8049(93)90040-m.

  PMID: 7507687 BACKGROUND

• Douillard JY, Schiller J. ZD0473 combined with other chemotherapeutic agents for the treatment of solid malignancies. Eur J Cancer. 2002 Dec;38 Suppl 8:S25-31. doi: 10.1016/s0959-8049(02)80020-x.

  PMID: 12645909 BACKGROUND

• Gelmon KA, Stewart D, Chi KN, Chia S, Cripps C, Huan S, Janke S, Ayers D, Fry D, Shabbits JA, Walsh W, McIntosh L, Seymour LK. A phase I study of AMD473 and docetaxel given once every 3 weeks in patients with advanced refractory cancer: a National Cancer Institute of Canada-Clinical Trials Group trial, IND 131. Ann Oncol. 2004 Jul;15(7):1115-22. doi: 10.1093/annonc/mdh278.

  PMID: 15205207 BACKGROUND

• Holford J, Raynaud F, Murrer BA, Grimaldi K, Hartley JA, Abrams M, Kelland LR. Chemical, biochemical and pharmacological activity of the novel sterically hindered platinum co-ordination complex, cis-[amminedichloro(2-methylpyridine)] platinum(II) (AMD473). Anticancer Drug Des. 1998 Jan;13(1):1-18.

  PMID: 9474239 BACKGROUND

• Holford J, Sharp SY, Murrer BA, Abrams M, Kelland LR. In vitro circumvention of cisplatin resistance by the novel sterically hindered platinum complex AMD473. Br J Cancer. 1998;77(3):366-73. doi: 10.1038/bjc.1998.59.

  PMID: 9472630 BACKGROUND

• Rogers P, Boxall FE, Allott CP, Stephens TC, Kelland LR. Sequence-dependent synergism between the new generation platinum agent ZD0473 and paclitaxel in cisplatin-sensitive and -resistant human ovarian carcinoma cell lines. Eur J Cancer. 2002 Aug;38(12):1653-60. doi: 10.1016/s0959-8049(02)00107-7.

  PMID: 12142057 BACKGROUND

Related Links

• Poniard Pharmaceuticals, Inc.

MeSH Terms

Conditions

Neoplasm Metastasis; Prostatic Neoplasms

Interventions

amminedichloro(2-methylpyridine)platinum(II); Docetaxel

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Robert Earhart, MD

  Poniard Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 15, 2007
• First Posted: March 19, 2007
• Study Start: June 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2010
• Last Updated: January 21, 2009

Record last verified: 2009-01

Locations

RU (11)