Know Cancer

or
forgot password

A Phase I Study of Oxaliplatin in Combination With Paclitaxel


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

A Phase I Study of Oxaliplatin in Combination With Paclitaxel


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.

Inclusion Criteria


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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Eric H. Kraut, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

OSU-99H0284

NCT ID:

NCT00004173

Start Date:

October 1999

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210