Status:
TERMINATED
Study of Satraplatin With Capecitabine to Treat Advanced Solid Malignancies
Lead Sponsor:
Agennix
Conditions:
Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the maximally tolerated dose (MTD) and Phase 2 recommended dose of satraplatin when administered in combination with capecitabine in patients with advanced so...
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 soli...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00329329
Start Date
May 1 2006
End Date
February 1 2009
Last Update
March 23 2012
Active Locations (1)
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1
Northwestern University Medical Center
Chicago, Illinois, United States, 60611