- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00329329
Study of Satraplatin With Capecitabine to Treat Advanced Solid Malignancies
Phase 1 Study of the Oral Platinum Agent Satraplatin in Combination With Capecitabine for the Treatment of Patients With Advanced Solid Malignancies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a single center, open-label, non-randomized, Phase I dose finding study of the investigational, oral cytotoxic drug, satraplatin in combination with capecitabine in patients with advanced solid tumors for whom curative therapy is not available. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.
PURPOSE: The purpose of this trial is to determine a tolerable dose and schedule for the combination of satraplatin and docetaxel when given to patients with advanced solid tumors.
WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
- Histologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative chemotherapy measures do not exist or are no longer effective
- Age > 18 years old
- ECOG Performance Status < 2
- Female patients may not be pregnant or lactating and must be willing to practice contraception
Adequate organ function as defined by the following:
- Serum creatinine < 1.5 mg/dl
- Absolute neutrophil count (ANC) > 1500/dL
- Platelets > 100,000/dL
- Total bilirubin < upper limit of normal (ULN) for the reference lab
- AST, ALT, and alkaline phosphatase must be within the designated range allowing for eligibility
Key Exclusion Criteria:
- Other chemotherapy treatment < 4 weeks prior to enrollment Treatment with capecitabine, 5-fluorouracil (5-FU), or a platinum agent < 3 months from time of enrollment
- Radiotherapy involving > 30% of the active bone marrow
- Radiotherapy < 4 weeks prior to enrollment
- Pre-existing peripheral neuropathy > grade 1
- Pre-existing hearing loss > grade 2
- Metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, had a negative imaging study within 4 weeks of study entry, is clinically stable with respect to the tumor at the time of study entry, and is not receiving steroid therapy or taper
Patients who have not recovered (> grade 1) from the following toxicities of previous regimens before enrollment:
- hematologic toxicities
- fatigue
- mucositis
- nausea/vomiting
- diarrhea
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation)
- 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 hypersensitivity reaction to capecitabine, 5-FU or any platinum containing drugs
- History of human immunodeficiency (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
- Evidence of concurrent second malignancy other than basal cell carcinoma of the skin or cervical carcinoma in situ
- Concurrent use of medications that inhibit cytochrome P450 3A4 (including aprepitant)
- History of bone marrow or major organ transplant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MTD
Time Frame: 2007
|
2007
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety
Time Frame: 2007
|
2007
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William Gradishar, MD, Northwestern University Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAT1-05-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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