Multimodality Phase II Study in Prostate Cancer

NCT00734851

Last updated date
Study Location
Johns Hopkins University
Baltimore, Maryland, 21218, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Prostate adenocarcinoma with evidence of recurrent disease as measured only by rising PSA, without evidence of metastatic disease by bone scan or CT scan within 4 weeks of entry

2. PSA ≤ 3.0 ng/ml and ≥ 0.1 ng/ml within 2 weeks of registration

3. Radical prostatectomy within 4 years of registration.

4. Rising PSA as defined by 1 or more PSA values greater than the nadir value after radical prostatectomy, separated by at least 4 weeks.

5. Gleason sum at radical prostatectomy of 7-10 (4+3 or 3+4 allowed)

6. Informed consent

7. Age > 18 years.

8. Adequate laboratory parameters:

- leukocytes ≥ 3,000/uL

- absolute neutrophil count ≥ 1,500/uL

- platelets ≥ 75,000/uL

- hemoglobin > 9.0 g/dl

- total bilirubin within normal institutional limit

- AST(SGOT)/ALT(SGPT) < 2.5x institutional upper limit

- creatinine < 2.0x institutional upper limit

9. Karnofsky Performance Status ≥ 80 (Attachment 2).

10. Written, signed, dated, and witnessed IRB approved informed consent form (ICF) before any screening procedures are performed.

11. Peripheral neuropathy ≤ grade 1

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Evidence of metastatic disease by CT scan, physical exam, or bone scan within 4 weeks
of registration


2. History of bleeding disorders or medical comorbidities that in the opinion of the
investigator would preclude the use of systemic chemotherapy


3. Prior systemic or biologic therapy, including pre-operative therapies or adjuvant
chemotherapy, biologic therapy, or hormonal therapy


4. Life expectancy of less than 5 years from medical co-morbidities by physician judgment


5. Non-adenocarcinoma prostate cancer pathology at radical prostatectomy


6. Prior radiotherapy to the abdomen or pelvis


7. Less than or equal to 6 weeks from prior major surgery, including radical
prostatectomy, open biopsy, or traumatic injury.


8. Recent cardiovascular event (within 12 months) including unstable angina, myocardial
infarction, severe or at rest claudication, or stroke/CVA.


9. Subjects receiving known strong CYP3A4 isoenzyme inhibitors and/or inducers. Subjects
on acceptable CYP3A4 isoenzyme inhibitors and/or inducers are eligible, provided they
have been taking a stable regimen for at least 4 weeks prior to screening.


10. Presence of a non-healing wound or ulcer.


11. Grade >= 3 hemorrhage within the past month.


12. Hypertension with systolic blood pressure of >140 mm Hg and/or diastolic pressure >90
mm Hg at the time of screening. Anti-hypertensive medications are permitted.


13. Subjects with American Heart Association (AHA) Class 2-4 heart disease or any history
of congestive heart failure with an ejection fraction <50%.


14. Subjects with inability to tolerate or absorb oral medications.


15. QTc interval >480 msec on baseline EKG. Subjects may not be taking a medication known
to significantly prolong the QTc interval.


16. Subjects who have not recovered from prior biopsy, surgery, traumatic injury, and/or
radiation therapy.


17. Anticoagulation with warfarin (therapeutic doses of warfarin for catheter patency are
permitted). Low molecular weight heparin is permitted.


18. Active infection(s), active antimicrobial therapy or serious intercurrent illness.


19. Any other major medical or psychiatric illness that, in the investigator's judgment,
will substantially increase the risk associated with the subject's participation in
this study, including inability to absorb oral medications.


20. Any history of hemoptysis within the past 12 months

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Prostate CancerA Study of Epirubicin With Estramustine Phosphate and Celecoxib for the Treatment of Prostate Cancer
NCT00218205
  1. East Orange, New Jersey
Male
18 Years+
years
MULTIPLE SITES
Prostate CancerMultimodality Phase II Study in Prostate Cancer
NCT00734851
  1. Baltimore, Maryland
  2. New Brunswick, New Jersey
  3. Durham, North Carolina
Male
18 Years+
years
MULTIPLE SITES
Prostate CancerStudy on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer
NCT02918968
  1. Nagoya, Aichi
  2. Nagoya, Aichi
  3. Matsuyama, Ehime
  4. Iizuka, Fukuoka
  5. Isesaki, Gunma
  6. Maebashi, Gunma
  7. Ota, Gunma
  8. Hakodate, Hokkaido
  9. Sapporo, Hokkaido
  10. Sapporo, Hokkaido
  11. Sapporo, Hokkaido
  12. Mito, Ibaraki
  13. Sagamihara, Kanagawa
  14. Yokohama, Kanagawa
  15. Yokohama, Kanagawa
  16. Yokosuka, Kanagawa
  17. Kashihara, Nara
  18. Kurashiki, Okayama
  19. Hirakata, Osaka
  20. Osakasayama, Osaka
  21. Suita, Osaka
  22. Kitaadachi-gun, Saitama
  23. Hamamatsu, Shizuoka
  24. Utsunomiya, Tochigi
  25. Bunkyo-ku, Tokyo
  26. Bunkyo-ku, Tokyo
  27. Koto-ku, Tokyo
  28. Nakano-ku, Tokyo
  29. Shinagawa-ku, Tokyo
  30. Shinjuku-ku, Tokyo
  31. Ube, Yamaguchi
  32. Chiba,
  33. Chiba,
  34. Fukuoka,
  35. Fukuoka,
  36. Fukuoka,
  37. Hiroshima,
  38. Kyoto,
  39. Nagano,
  40. Nagano,
  41. Nagasaki,
  42. Osaka,
  43. Osaka,
  44. Osaka,
  45. Saga,
  46. Tokushima,
  47. Toyama,
Male
20 Years+
years
MULTIPLE SITES
Prostate CancerPalbociclib in Patients With Metastatic Castration-Resistant Prostate Cancer
NCT02905318
  1. Edmonton, Alberta
  2. Vancouver, British Columbia
  3. Halifax, Nova Scotia
  4. Hamilton, Ontario
  5. London, Ontario
  6. Ottawa, Ontario
  7. Toronto, Ontario
  8. Montreal, Quebec
  9. Montreal, Quebec
  10. Regina, Saskatchewan
  11. Saskatoon, Saskatchewan
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Multimodality Phase II Study in Prostate Cancer
Official Title  ICMJE Multimodality Therapy for Recurrent High Risk Prostate Cancer: A Phase II Study
Brief Summary This is a single arm phase II study of docetaxel, prednisone, and sunitinib systemic therapy followed by salvage external beam radiation therapy for men who have experienced PSA recurrence following initial radical prostatectomy for prostate cancer. The primary aim is the rate of progression-free survival at 2 years as measured by lack of PSA progression and no evidence of disease. We hypothesize that this aggressive initial systemic therapy will improve the long term remission rates for men who are undergoing salvage radiation therapy for PSA recurrence in the absence of metastatic disease.
Detailed Description

In many common malignancies such as breast cancer, trimodality therapy represents the standard-of-care approach, including initial surgical resection followed by systemic chemotherapy followed by radiotherapy for optimal local control, and targeted hormonal or biologic therapy for a period of time to reduce the ongoing risk of systemic disease recurrence. These approaches have reduced recurrence rates and improved overall survival in the adjuvant setting in breast cancer; however, the treatment of men with PSA recurrence following radical prostatectomy has generally been unsatisfying, given the high rates of persistent or recurrent disease despite salvage radiotherapy.

The primary purpose of the study is to determine the rate of biochemical (PSA) progression free survival (bPFS) in men with PSA recurrent non-metastatic prostate cancer following radical prostatectomy, who receive multimodality therapy consisting of local salvage external beam radiotherapy and systemic docetaxel-based chemotherapy plus the targeted anti-VEGF biologic therapy sunitinib. Biochemical PFS will be defined as the proportion of subjects at 24 months, post-registration, with one of the following: 1) a serum PSA value of 0.2 ng/ml or more above the post-radiotherapy PSA nadir and confirmed 4 weeks later by a second PSA measurement that was higher than the first by any amount, 2) a continued rise in the PSA level following study treatment if no nadir is experienced, defined as 2 rising values greater than the baseline PSA and separated by at least 4 weeks, 3) evidence of clinical progression or initiation of systemic therapy for progressive disease, or 4) death. Secondary objectives include finding the rate of biochemical (PSA) disease free survival over time, Two-, three-, five-, and six- year risk of local recurrence (proportion), two-, three-, five-, and six-year risk of metastases and metastasis-free survival, two-, three-, five-, and six-year risk of metastases and metastasis-free survival, Safety, feasibility, and tolerability as assessed by NCI Common Toxicity Scales (v3.0), quality of life questionnaire (EPIC-short form surveys), achievement of accrual goals. Finally, a comparison of RNA expression profiles from original prostate radical prostatectomy specimen among those with PSA relapse at 2 and 5 years as compared to those without PSA relapse at the primary endpoint.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Docetaxel
    Docetaxel 70 mg/m2 day 1 every 3 weeks for 4 cycles with prednisone 5 mg orally twice daily
    Other Name: Taxotere
  • Drug: Sunitinib
    Sunitinib 37.5 mg orally once daily for 14 days followed by 7 days off, for 4 cycles, concurrent with docetaxel and prednisone
    Other Name: Sutent
  • Radiation: EBXRT
    External beam radiotherapy to the prostate bed, started on day 100, after completion of chemotherapy. 66 Gy over 6-7 weeks.
    Other Name: IMRT
Study Arms  ICMJE Experimental: Multimodality
4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks
Interventions:
  • Drug: Docetaxel
  • Drug: Sunitinib
  • Radiation: EBXRT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 27, 2013)
36
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2008)
38
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Prostate adenocarcinoma with evidence of recurrent disease as measured only by rising PSA, without evidence of metastatic disease by bone scan or CT scan within 4 weeks of entry
  2. PSA ? 3.0 ng/ml and ? 0.1 ng/ml within 2 weeks of registration
  3. Radical prostatectomy within 4 years of registration.
  4. Rising PSA as defined by 1 or more PSA values greater than the nadir value after radical prostatectomy, separated by at least 4 weeks.
  5. Gleason sum at radical prostatectomy of 7-10 (4+3 or 3+4 allowed)
  6. Informed consent
  7. Age > 18 years.
  8. Adequate laboratory parameters:

    • leukocytes ? 3,000/uL
    • absolute neutrophil count ? 1,500/uL
    • platelets ? 75,000/uL
    • hemoglobin > 9.0 g/dl
    • total bilirubin within normal institutional limit
    • AST(SGOT)/ALT(SGPT) < 2.5x institutional upper limit
    • creatinine < 2.0x institutional upper limit
  9. Karnofsky Performance Status ? 80 (Attachment 2).
  10. Written, signed, dated, and witnessed IRB approved informed consent form (ICF) before any screening procedures are performed.
  11. Peripheral neuropathy ? grade 1

Exclusion Criteria:

  1. Evidence of metastatic disease by CT scan, physical exam, or bone scan within 4 weeks of registration
  2. History of bleeding disorders or medical comorbidities that in the opinion of the investigator would preclude the use of systemic chemotherapy
  3. Prior systemic or biologic therapy, including pre-operative therapies or adjuvant chemotherapy, biologic therapy, or hormonal therapy
  4. Life expectancy of less than 5 years from medical co-morbidities by physician judgment
  5. Non-adenocarcinoma prostate cancer pathology at radical prostatectomy
  6. Prior radiotherapy to the abdomen or pelvis
  7. Less than or equal to 6 weeks from prior major surgery, including radical prostatectomy, open biopsy, or traumatic injury.
  8. Recent cardiovascular event (within 12 months) including unstable angina, myocardial infarction, severe or at rest claudication, or stroke/CVA.
  9. Subjects receiving known strong CYP3A4 isoenzyme inhibitors and/or inducers. Subjects on acceptable CYP3A4 isoenzyme inhibitors and/or inducers are eligible, provided they have been taking a stable regimen for at least 4 weeks prior to screening.
  10. Presence of a non-healing wound or ulcer.
  11. Grade >= 3 hemorrhage within the past month.
  12. Hypertension with systolic blood pressure of >140 mm Hg and/or diastolic pressure >90 mm Hg at the time of screening. Anti-hypertensive medications are permitted.
  13. Subjects with American Heart Association (AHA) Class 2-4 heart disease or any history of congestive heart failure with an ejection fraction <50%.
  14. Subjects with inability to tolerate or absorb oral medications.
  15. QTc interval >480 msec on baseline EKG. Subjects may not be taking a medication known to significantly prolong the QTc interval.
  16. Subjects who have not recovered from prior biopsy, surgery, traumatic injury, and/or radiation therapy.
  17. Anticoagulation with warfarin (therapeutic doses of warfarin for catheter patency are permitted). Low molecular weight heparin is permitted.
  18. Active infection(s), active antimicrobial therapy or serious intercurrent illness.
  19. Any other major medical or psychiatric illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study, including inability to absorb oral medications.
  20. Any history of hemoptysis within the past 12 months
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00734851
Other Study ID Numbers  ICMJE Pro00010747
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • Pfizer
  • Sanofi
Investigators  ICMJE
Principal Investigator:Andrew J Armstrong, MD, ScMDuke University
PRS Account Duke University
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP