AzTrials
AzTrials

PainPhase 3NCT00003232

Combination Chemotherapy in Treating Pain in Hormone Refractory Metastatic Prostate Cancer

A Phase 3 study testing clodronate disodium, mitoxantrone hydrochloride and prednisone in people with Pain and Prostate Cancer, run by NCIC Clinical Trials Group at 21 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Some drugs used in chemotherapy can reduce the pain experienced by some people with cancer. Combining more than one drug may be more effective at reducing cancer pain. Read more about this study

Who is it for?
Ages Up to 120 years, men only
Conditions the study is for
Pain, Prostate Cancer, Quality of Life
What is being tested?
clodronate disodium, mitoxantrone hydrochloride and prednisone
Type of treatment
Surgery or procedure
How many people
227 participants
Where
21 sitesCanada
Study dates
24 Nov 1997to 10 Feb 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 120 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate or metastatic carcinoma of presumptive prostate origin as manifest by the presence of sclerotic bony metastases and a serum PSA level greater than the upper limit of normal Radiologically proven progressive bone disease (e.g., new bone scan lesions, increased uptake of isotope at previous sites of disease, and/or increasing bone pain) Hormone refractory disease (i.e., disease progression or recurrence despite documented castrate levels of serum testosterone achieved by bilateral orchiectomy or antiandrogen therapy) Bone pain due to metastatic disease Patients must have achieved stable analgesia for at least 7 days No uncontrolled epidural metastases

PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-3 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 3.15 mg/dL Renal: Creatinine less than 2.26 mg/dL Serum calcium no greater than 3.1 mmol/L Cardiovascular: Patients with history of angina pectoris, previous cardiac infarction, hypertension, or valvular or congenital heart disease must have baseline measurement of LVEF exceeding 50% Other: No other malignancy within 5 years except nonmelanomatous skin cancer No active infection or any other contraindication to chemotherapy with mitoxantrone No spinal cord or nerve root compression No unstabilized impending pathological fractures

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: One previous course of chemotherapy allowed No prior mitoxantrone or other anthracycline Endocrine therapy: See Disease Characteristics At least 4 weeks since prior nonsteroidal antiandrogens Radiotherapy: At least 4 weeks since prior radiotherapy At least 8 weeks since prior strontium-89 or samarium-153 Surgery: Not specified Other: No prior bisphosphonate therapy

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Canada21 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Queen Elizabeth Hospital, PEI

    Charlottetown, Prince Edward Island, C1A 8T5

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Cancer Care Ontario-Hamilton Regional Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Kingston Regional Cancer Centre

    Kingston, Ontario, K7L 5P9

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Trillium Health Centre

    Mississauga, Ontario, L5B 1B8

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6

  • Ottawa Regional Cancer Center - General Division

    Ottawa, Ontario, K1H 8L6

  • Penticton Regional Hospital

    Penticton, British Columbia, V2A 3G6

  • Peterborough Oncology Clinic

    Peterborough, Ontario, K9H 7B6

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Hotel Dieu Hospital - St. Catharines

    St. Catharines, Ontario, L2R 5K3

  • Newfoundland Cancer Treatment and Research Foundation

    St. John's, Newfoundland and Labrador, A1B 3V6

  • British Columbia Cancer Agency - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Northwestern Ontario Regional Cancer Centre, Thunder Bay

    Thunder Bay, Ontario, P7A 7T1

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • B.C. Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

  • Humber River Regional Hospital

    Weston, Ontario, M9N 1N8

  • Cancer Care Ontario - Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

Other trials in Canada

About this study

Official title: Randomized Placebo-Controlled Trial of Mitoxantrone/Prednisone and Clodronate Versus Mitoxantrone/Prednisone Alone in Patients With Hormone Refractory Metastatic Prostate Cancer and Pain

RATIONALE: Some drugs used in chemotherapy can reduce the pain experienced by some people with cancer. Combining more than one drug may be more effective at reducing cancer pain. It is not known whether receiving combination chemotherapy with clodronate is more effective than receiving combination chemotherapy without clodronate for hormone refractory metastatic prostate cancer.

PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of combination chemotherapy using mitoxantrone plus prednisone with or without clodronate in treating pain in patients with hormone refractory metastatic prostate cancer.

Read the detailed description

OBJECTIVES: I. Compare the effect of mitoxantrone and prednisone with or without clodronate on localized bone pain in patients with hormone refractory metastatic prostate cancer. II. Compare the overall survival and quality of life of these patients after these treatments.

OUTLINE: This is a randomized, double blinded, placebo controlled, multicenter study. Patients are stratified according to quality of pain (mild vs moderate) and previous corticosteroids or one regimen of non-anthracycline-containing cytotoxic chemotherapy (e.g., estramustine) vs none. Patients are assigned to 1 of 2 treatment arms. Arm I consists of oral prednisone twice a day and intravenous mitoxantrone followed by intravenous clodronate administered over 3 hours every 3 weeks. Arm II consists of oral prednisone twice a day and intravenous mitoxantrone followed by intravenous placebo administered over 3 hours every 3 weeks. Doses are adjusted for myelosuppression. Treatment continues until disease progression (although patients initially on placebo can continue on open-label clodronate) or until the maximum cumulative dose of mitoxantrone is reached. Patients with a palliative response may continue on prednisone and the study drug (clodronate or placebo) until disease progression. Quality of life is assessed before and every 3 weeks during study treatment. A daily pain diary is also maintained. All patients are followed at 2 weeks and then every 3 months until death.

PROJECTED ACCRUAL: This study will accrue 204 patients.

Being tested
clodronate disodium, mitoxantrone hydrochloride, prednisone, quality-of-life assessment
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, pain, quality of life
Medical subject headings
Pain, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clodronate disodiumDrug

  • mitoxantrone hydrochlorideDrug

  • prednisoneDrug

  • quality-of-life assessmentProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2004 (estimated)
  2. Study start24 Nov 1997
  3. Primary completion1 May 2002
  4. Study completion10 Feb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003232
Sponsor's protocol ID
PR6
Other IDs
CAN-NCIC-PR6, CDR0000066102
Status last verified
Apr 2020
First submitted
1 Nov 1999
Last updated
3 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Taylor SK, Ding K, Ernst SD, et al.: Palliative response measurement in a phase III study of patients with prostate cancer and painful bone metastases: secondary analysis of NCIC-CTG PR6. [Abstract] J Clin Oncol 26 (Suppl 15): A-9636, 2008.

  • Ernst DS, Tannock IF, Winquist EW, Venner PM, Reyno L, Moore MJ, Chi K, Ding K, Elliott C, Parulekar W. Randomized, double-blind, controlled trial of mitoxantrone/prednisone and clodronate versus mitoxantrone/prednisone and placebo in patients with hormone-refractory prostate cancer and pain. J Clin Oncol. 2003 Sep 1;21(17):3335-42. doi: 10.1200/JCO.2003.03.042.

    PubMed 12947070

  • Jakob T, Tesfamariam YM, Macherey S, Kuhr K, Adams A, Monsef I, Heidenreich A, Skoetz N. Bisphosphonates or RANK-ligand-inhibitors for men with prostate cancer and bone metastases: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 3;12(12):CD013020. doi: 10.1002/14651858.CD013020.pub2.

    PubMed 33270906

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing clodronate disodium, mitoxantrone hydrochloride and prednisone in people with Pain and Prostate Cancer, run by NCIC Clinical Trials Group at 21 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003232, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in