A Phase I Study of the Oral Platinum Agent Satraplatin in Combination With Weekly Docetaxel

Stopped early · Phase 1

Conditions studied: Tumors, Prostate Cancer

In brief

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 is determined, an additional 6 patients, all with chemotherapy-naïve HRPC, will be enrolled. Once a recommended dose(s) (RD(s)) for phase 2 studies has/have been determined, 6 additional patients with chemotherapy-naïve HRPC will be enrolled at the RD to further evaluate safety and efficacy.

Key facts

Study ID: NCT00313456
Run by: Agennix
People needed: 25
Starts: 2006-03-01
Expected to finish: 2009-03-01
Last updated by the study team: 2012-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Sarah Cannon Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.