Status:
COMPLETED
S0354, Anti-IL-6 Chimeric Monoclonal Antibody in Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as anti-IL-6 chimeric monoclonal antibody, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor ...
Detailed Description
OBJECTIVES: Primary * Assess the confirmed prostate-specific antigen response in patients with hormone-refractory metastatic prostate cancer treated with anti-IL-6 chimeric monoclonal antibody. Sec...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Metastatic disease (N1 and/or M1)
- Disease unresponsive or refractory to androgen-deprivation therapy
- Must have received only 1 prior chemotherapy regimen comprising a taxane OR mitoxantrone
- Disease progression as defined by one or more of the following:
- Progression of measurable disease
- Prior radiotherapy allowed provided radiotherapy was completed ≥ 2 months ago and lesion progressed since radiotherapy
- Progression of nonmeasurable disease
- Prior radiotherapy within the past 2 months allowed, but disease is considered nonmeasurable
- Rising prostate-specific antigen (PSA) after \> 2 courses of chemotherapy OR within 6 months of last chemotherapy dose
- Rising PSA defined as at least 2 consecutive rises in PSA to be documented over a reference value (measure 1)
- PSA ≥ 5 ng/mL
- Surgical or medical castration required
- Castration using luteinizing hormone-releasing hormone agonist (leuprolide acetate or goserelin) or antagonist (abarelix) should not be interrupted
- No history of brain metastases OR currently treated or untreated brain metastases
- Patients with clinical suspicion of brain metastases must have a brain CT scan or MRI negative for metastatic disease within the past 56 days
- PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Fertile patients must use effective contraception
- Absolute granulocyte count ≥ 1,500/mm³ (transfusion independent)
- Platelet count ≥ 100,000/mm³ (transfusion independent)
- Hemoglobin ≥ 9 g/dL (transfusion independent)
- Creatinine clearance ≥ 40 mL/min
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST) ≤ 2 times ULN
- No uncontrolled intercurrent illnesses including, but not limited to, the following:
- Diabetes mellitus
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- No psychiatric illness or social situation that would preclude study compliance
- No known HIV positivity
- No other prior malignancy except for the following:
- Adequately treated basal cell or squamous cell skin cancer
- Adequately treated stage I or II cancer in complete remission
- Any other cancer from which the patient has been disease-free for 5 years
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 21 days since prior surgery and recovered
- At least 28 days since prior chemotherapy and recovered
- At least 28 days since prior flutamide or ketoconazole
- At least 28 days since prior radiotherapy (to \< 30% of the bone marrow only) and recovered
- Prior samarium Sm 153 lexidronam pentasodium allowed
- No prior strontium chloride Sr 89
- At least 42 days since prior bicalutamide or nilutamide
- More than 60 days since prior murine or chimeric proteins or human/murine monoclonal antibody
- Concurrent bisphosphonate therapy allowed provided the following are true:
- Therapy commenced at least 3 weeks ago
- Therapy continues for the entire duration of study treatment
- No other concurrent anticancer therapy, including cytotoxic therapy, biologic therapy, radiotherapy, or hormonal therapy (except for luteinizing hormone-releasing hormone agonist or antagonist in patients who have not had an orchiectomy)
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00433446
Start Date
April 1 2007
End Date
July 1 2011
Last Update
February 5 2013
Active Locations (123)
Enter a location and click search to find clinical trials sorted by distance.
1
Regional Medical Center
Anniston, Alabama, United States, 36202
2
Highlands Oncology Group - Springdale
Springdale, Arkansas, United States, 72764
3
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704
4
Peninsula Medical Center
Burlingame, California, United States, 94010