Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer

NCT ID: NCT00004173

Last Updated: 2013-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-10-31

Brief Summary

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.

Detailed 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

oxaliplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Eric H. Kraut, MD

Role: STUDY_CHAIR

Ohio State University Comprehensive Cancer Center

Locations

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

CDR0000067419

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-T99-0017

Identifier Type: -

Identifier Source: secondary_id

OSU-99H0284

Identifier Type: -

Identifier Source: org_study_id