Multimodality Phase II Study in Prostate Cancer

NCT00734851 | Terminated Phase 2 Results DMC

• 1 other identifier: Pro00010747
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; sunitinib; docetaxel; PSA; radiation; PSA recurrence; No metastatic disease

Outcome Measures

Primary Outcomes (1)

• The Rate of Progression Free Survival (PFS) at 24 Months

  Percentage of participants surviving 24 months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression will be defined as having experienced any of the following: a serum prostate specific antigen (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, 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, or evidence of clinical progression or initiation of systemic therapy for progressive disease.

  2 years

Secondary Outcomes (6)

• Proportion of Biochemical Progression (bPFS Proportion) at 2 and 3 Years.

  24 months and 36 months

• Rate of Local Recurrence at 2 and 3 Years

  24 months and 36 months

• Metastasis-free Survival (MFS) Rates at 2 and 3 Years.

  2 and 3 years

• Change in Quality of Life (QoL) After 1 Year

  baseline and 1 year

• Change in Quality of Life (QoL) After 3 Month

  baseline and 3 months

Study Arms (1)

Multimodality

EXPERIMENTAL

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

Drug: Docetaxel; Drug: Sunitinib; Radiation: EBXRT

Interventions

Docetaxel DRUG

Docetaxel 70 mg/m2 day 1 every 3 weeks for 4 cycles with prednisone 5 mg orally twice daily

Also known as: Taxotere

Multimodality

Sunitinib DRUG

Sunitinib 37.5 mg orally once daily for 14 days followed by 7 days off, for 4 cycles, concurrent with docetaxel and prednisone

Also known as: Sutent

Multimodality

EBXRT RADIATION

External beam radiotherapy to the prostate bed, started on day 100, after completion of chemotherapy. 66 Gy over 6-7 weeks.

Also known as: IMRT

Multimodality

Eligibility Criteria

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

You may qualify if:

• 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
• PSA ≤ 3.0 ng/ml and ≥ 0.1 ng/ml within 2 weeks of registration
• Radical prostatectomy within 4 years of registration.
• Rising PSA as defined by 1 or more PSA values greater than the nadir value after radical prostatectomy, separated by at least 4 weeks.
• Gleason sum at radical prostatectomy of 7-10 (4+3 or 3+4 allowed)
• Informed consent
• Age \> 18 years.
• 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

You may not qualify if:

• Evidence of metastatic disease by CT scan, physical exam, or bone scan within 4 weeks of registration
• History of bleeding disorders or medical comorbidities that in the opinion of the investigator would preclude the use of systemic chemotherapy
• Prior systemic or biologic therapy, including pre-operative therapies or adjuvant chemotherapy, biologic therapy, or hormonal therapy
• Life expectancy of less than 5 years from medical co-morbidities by physician judgment
• Non-adenocarcinoma prostate cancer pathology at radical prostatectomy
• Prior radiotherapy to the abdomen or pelvis
• Less than or equal to 6 weeks from prior major surgery, including radical prostatectomy, open biopsy, or traumatic injury.
• Recent cardiovascular event (within 12 months) including unstable angina, myocardial infarction, severe or at rest claudication, or stroke/CVA.
• 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.
• Presence of a non-healing wound or ulcer.
• Grade \>= 3 hemorrhage within the past month.
• 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.
• Subjects with American Heart Association (AHA) Class 2-4 heart disease or any history of congestive heart failure with an ejection fraction \<50%.
• Subjects with inability to tolerate or absorb oral medications.
• QTc interval \>480 msec on baseline EKG. Subjects may not be taking a medication known to significantly prolong the QTc interval.

Sponsors & Collaborators

• Duke University: lead
• Pfizer: collaborator
• Sanofi: collaborator

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

The Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Sunitinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; 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; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Andrew J. Armstrong, MD ScM FACP
• Organization: DukeUMC

andrew.armstrong@duke.edu

(919) 668-8797

Study Officials

• Andrew J Armstrong, MD, ScM

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 14, 2008
• Study Start: December 1, 2008
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 23, 2015
• Results First Posted: December 23, 2015

Record last verified: 2015-09

Locations

US (3)