Completed

A Phase I Study of Oxaliplatin in Combination With Gemcitabine

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What is being tested

gemcitabine hydrochloride

+ oxaliplatin

Drug
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: October 1999
See protocol details

Summary

Principal SponsorCity of Hope Medical Center
Last updated: January 13, 2010
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 1999

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicities of gemcitabine in combination with oxaliplatin in patients with advanced malignancies. II. Determine the pharmacokinetics of oxaliplatin and gemcitabine in these patients. OUTLINE: This is a multicenter, dose escalation study of gemcitabine. Patients receive oxaliplatin IV over 2 hours on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine in combination with a fixed dose of oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity. PROJECTED ACCRUAL: A total of 24-36 patients will be accrued for this study within 2 years.

NCT00004220
Principal SponsorCity of Hope Medical Center
Last updated: January 13, 2010
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic or unresectable malignancy for which standard therapy does not exist or is no longer effective No greater than 3 prior treatment regimens No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 3000/mm3 Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: No clinically significant neuropathy Not pregnant or nursing Fertile patients must use effective contraception No allergy to platinum compounds or antiemetics No uncontrolled active infection or other illness PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics No prior radiotherapy to at least 30% of bone marrow At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: No other concurrent investigational agents No other concurrent anticancer therapy No HIV positive patients receiving antiretroviral therapy (HAART)

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Cancer Center and Beckman Research Institute, City of Hope

Duarte, United StatesOpen Cancer Center and Beckman Research Institute, City of Hope in Google Maps

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, United States

University of California Davis Cancer Center

Sacramento, United States
Completed3 Study Centers