Status:
TERMINATED
A Phase I Study of the Oral Platinum Agent Satraplatin in Combination With Weekly Docetaxel
Lead Sponsor:
Agennix
Conditions:
Tumors
Prostate Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a single-center, open-label (sequential-group dose-escalation dose-finding) phase I study of satraplatin and docetaxel in patients who have received prior chemotherapy regimens. Once the MTD i...
Detailed Description
RATIONALE: Satraplatin is an oral platinum analog that is currently being evaluated in combination with prednisone in a phase III clinical trial in patients with HRPC who have progressed following on...
Eligibility Criteria
Inclusion
- Histologically proven advanced solid tumors.
- 2 prior chemotherapy regimens.
- Age greater than or equal to 18 years.
- Eastern Cooperative Oncology Group performance status 0-1.
- Life expectancy greater than 3 months.
- At least 4 weeks between prior surgery or radiotherapy and enrollment.
- Adequate organ function as defined by the following criteria (must be obtained within 1 week of the first day of treatment):
- Absolute neutrophil count ≥ 1500/µL. Hemoglobin ≥ 10.0 g/dl. Platelets ≥ 100,000/µL. Serum creatinine ≤ 1.5 upper limit of normal (ULN). Serum bilirubin ≤ ULN. AST/ALT ≤ 1.5 x the ULN.
- Patients must be able to swallow capsules.
- Patients must give written informed consent before study participation.
- No history of another cancer within the past 5 years (except basal or squamous cell carcinoma of the skin).
- No brain or leptomeningeal metastases.
- Female patients must not be pregnant or lactating and must be willing to practice contraception. Males must agree to contraceptive practices.
- For HRPC cohort
- Patient must continue to be administered an LHRH agonist if they were receiving it at the time of screening for entry onto this protocol. Patients who have undergone bilateral orchiectomy do not need to be on LHRH agonists.
- Patient must be off of anti-androgen medications for ≥ 6 weeks.
- Patient must have castrate level of testosterone (\< 50 ng/dL).
- Progressive HRPC as defined by one of the following:
- Rising PSA
- Sequential imaging studies
- Clinical suspicion in the view of the treating physician
Exclusion
- Patients who are unwilling to use contraception.
- Patients with a history of major gastrointestinal surgery.
- Pre-existing peripheral neuropathy \> grade 1.
- Pre-existing edema \> grade 1.
- Patients with hearing loss or tinnitus \> grade 2.
- Prior RT to \>25% of the bone marrow.
- Concomitant use of medications that inhibit cytochrome P450 3A4 (including aprepitant).
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for non-FDA - approved indications and in the context of a research investigation).
- Patients who have not recovered (≥ grade 1) from the following toxicities of previous regimens before enrollment:
- hematologic toxicities (parameters defined in protocol
- fatigue
- mucositis
- nausea/vomiting/diarrhea.
- Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, uncontrolled congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements.
- History of HIV or AIDS related illness.
- History of severe hypersensitivity reaction to docetaxel, polysorbate, or other drugs formulated with polysorbate 80.
- Evidence of concurrent second malignancy.
- History of bone marrow or major organ transplant.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00313456
Start Date
March 1 2006
End Date
March 1 2009
Last Update
May 10 2012
Active Locations (1)
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1
Sarah Cannon Research Institute
Nashville, Tennessee, United States