| Satraplatin and Prednisone in Treating Patients With Progressive, Metastatic Prostate Cancer |
| A Phase II Study of Satraplatin and Prednisone in Metastatic Androgen Independent Prostate Cancer (AIPC) |
RATIONALE: Drugs used in chemotherapy, such as satraplatin and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving satraplatin together with prednisone may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving satraplatin together with prednisone works in treating patients with progressive, metastatic prostate cancer. |
OBJECTIVES:
Primary
- To determine if the presence of ERCC1 variant gene polymorphism may be associated with an impact on the progression-free survival of patients with metastatic androgen-independent prostate cancer.
Secondary
- To measure the overall response rate and overall survival in a post-hoc analysis.
- To demonstrate the biologic effect of satraplatin in white blood cell collections and in the tumor whenever possible.
- To determine the correlation of biologic or clinical effects with prostate-specific antigen (PSA) progression.
- To determine the incidence of different gene polymorphisms by genotyping using polymerase-chain reaction (PCR) followed by either restriction fragment length polymorphism or direct sequencing to genotype single nucleotide polymorphisms of ERCC1, XRCC1, and PARP1.
- To evaluate the correlation between genotype expression, repair pathways, and clinical events.
OUTLINE: Patients receive oral satraplatin once daily on days 1-5 and oral prednisone twice daily on days 1-35. Courses repeat every 35 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically and analyzed for genotyping of ERCC1 and other gene polymorphisms via polymerase chain reaction (PCR). |
| Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled |
| Progression-free survival [ Designated as safety issue: No ] |
Overall survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Genotyping [ Designated as safety issue: No ]
Prostate-specific antigen [ Designated as safety issue: No ]
Molecular endpoints [ Designated as safety issue: No ] |
| Prostate Cancer |
Drug: prednisone
Drug: satraplatin
Procedure: gene expression analysis
Procedure: pharmacological study
Procedure: polymerase chain reaction
Procedure: polymorphism analysis |
|
Clinical trial summary from the National Cancer Institute's PDQ® database  |
|
| Recruiting |
| 66 |
| September 2007 |
|
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer, meeting the following criteria:
- Metastatically progressive disease
- Androgen-independent disease
- Patients whose pathology specimens are not available may be enrolled in the trial provided the patient has a clinical course consistent with prostate cancer and available documentation from an outside pathology laboratory of the diagnosis
Must have radiographic evidence of disease by CT scan or bone scan that has continued to progress after primary treatment despite hormonal agents
Must have progressive disease after 1 prior cytotoxic chemotherapy but may have had no more than 1 previous cytotoxic chemotherapeutic line
- Multiple courses of a taxane-based regimen may count as a single regimen
- Multiple courses of a non-taxane agent or a combination chemotherapy regimen may count as a single regimen
- Patients who have not undergone bilateral surgical castration must continue suppression of testosterone production by appropriate usage of GnRH agonists
- No known active brain metastases
PATIENT CHARACTERISTICS:
Inclusion criteria:
- ECOG performance status 0-2
- Life expectancy > 3 months
- Leukocytes ≥ 3,000/μL
- Absolute neutrophil count ≥ 1,500/μL
- Platelets ≥ 100,000/μL
- Total bilirubin ≤ 1.5 times upper limits of normal (ULN) (except for patients with Gilbert disease)
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
- No ongoing malignancies requiring active therapy
- Fertile patients must use effective contraception
- Must be able to swallow capsules
- Able to understand and sign an informed consent
Exclusion criteria:
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to satraplatin or prednisone
Uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active serious infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Psychiatric illness/social situations that would limit patient compliance with study requirements
- HIV positivity
Diseases where corticosteroids are contraindicated, (e.g. , active gastric or duodenal ulcer, or poorly-controlled insulin dependent diabetes)
- Well-controlled insulin-dependent diabetes mellitus allowed provided the patient understands that their glucose levels will increase which will require their insulin dose to be adjusted
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
- Prior satraplatin or other platinum-containing compounds
- Prior radiotherapy to > 30% of the bone marrow
- Prior strontium chloride Sr 89, rhenium Re186, or rhenium Re188
- Prior major gastrointestinal surgery or pathology likely to influence absorption of oral medications (i.e., bypass surgeries, Whipple's procedure, or any surgery that would impair reliable absorption of oral drugs)
- Concurrent prophylactic growth factor support
- Concurrent anticancer treatment with chemotherapy, radiotherapy, major surgical procedures for prostate cancer, or nonprotocol-related immunotherapy
- Other concurrent investigational or commercial agents or therapies other than those used for this study with the intent to treat the patient's malignancy
|
| Male |
| 18 Years and older |
| No |
|
| United States |
|
| NCT00634647 |
| CDR0000589015 |
| NCI-08-C-0074, NCI-P07140 |
| National Cancer Institute (NCI) |
|
| Principal Investigator: |
William Dahut, MD |
National Cancer Institute (NCI) |
|
|
| National Cancer Institute (NCI) |
| March 2008 |
| March 12, 2008 |
| July 23, 2008 |