This trial is active, not recruiting.

Condition unspecified adult solid tumor, protocol specific
Treatments oxaliplatin, paclitaxel
Phase phase 1
Sponsor Ohio State University Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date October 1999
Trial identifier NCT00004173, CDR0000067419, NCI-T99-0017, OSU-99H0284


RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of oxaliplatin and paclitaxel in treating patients who have metastatic or unresectable cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically proven metastatic or unresectable malignancy for which standard curative or palliative measures do not exist or are no longer effective - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 - Karnofsky 50-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 3000/mm^3 - Absolute neutrophil count at least 1500/mm^3 - Platelet count at least 100,000/mm^3 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 neuropathy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No allergy to platinum compounds or antiemetics - No uncontrolled concurrent illness - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No more than 2 prior chemotherapy regimens - No prior oxaliplatin or paclitaxel - At least 4 weeks since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy - No prior radiotherapy to more than 25% of bone marrow Surgery: - Not specified Other: - No other concurrent investigational agents - No concurrent antiretroviral therapy for HIV (HAART)

Additional Information

Official title A Phase I Study of Oxaliplatin in Combination With Paclitaxel
Description OBJECTIVES: - Determine the maximum tolerated dose of oxaliplatin and paclitaxel in patients with metastatic or unresectable cancer. - Determine the qualitative and quantitative toxicities of this regimen in these patients. - Determine the therapeutic response to this regimen in these patients. - Determine the relationship between the pharmacokinetics of this regimen and toxicity and response in these patients. - Determine the effects of oxaliplatin on peripheral blood cells and correlate this to pharmacokinetics, toxicity, and response in these patients. OUTLINE: This is a dose escalation study. Patients receive oxaliplatin IV over 2 hours followed by paclitaxel IV over 1 hour weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oxaliplatin and paclitaxel 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: Approximately 20 patients will be accrued for this study within 12-18 months.
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).