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Phase 1 Study of the Oral Platinum Agent Satraplatin in Combination With Capecitabine for the Treatment of Patients With Advanced Solid Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Malignancies

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Trial Information

Phase 1 Study of the Oral Platinum Agent Satraplatin in Combination With Capecitabine for the Treatment of Patients With Advanced Solid Malignancies


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD

Outcome Time Frame:

2007

Safety Issue:

Yes

Principal Investigator

William Gradishar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

SAT1-05-02

NCT ID:

NCT00329329

Start Date:

May 2006

Completion Date:

February 2009

Related Keywords:

  • Malignancies
  • Advanced solid malignancies
  • Neoplasms

Name

Location

Northwestern University Medical CenterChicago, Illinois  60611