Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Oxaliplatin; Paclitaxel

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)