Safety Study of Combination Chemotherapy in Patients With Metastatic Solid Tumors or Adenocarcinoma of the Pancreas

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

Summary

The purpose of this trial is to determine the maximum tolerated dose and the dose-limiting toxicity of biweekly oxaliplatin in combination with fixed doses of irinotecan, 5-fluorouracil/leucovorin and gemcitabine in patients with metastatic solid tumors or adenocarcinoma of the pancreas.

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

Details

• Lead Sponsor: St. Luke's-Roosevelt Hospital Center
• Collaborator: Sanofi
• Treatments: Fluorouracil; Gemcitabine; Irinotecan; Leucovorin; Oxaliplatin; Pancreatin; Pancrelipase

Criteria

Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of a solid tumor, OR advanced or metastatic disease that is refractory to conventional treatment or for which no standard therapy exists.

2. Age > 18 years old.

3. A performance status of ≥ 60 on the Karnofsky scale

4. Life expectancy of at least 12 weeks.

5. Patients must give written informed consent as per institutional and federal regulatory requirements.

6. No chemotherapy, immunotherapy or radiotherapy for at least four weeks prior to entry in the study (six weeks for nitrosureas or mitomycin C). Patients may not receive concurrent chemotherapy, immunotherapy or radiotherapy while participating in this study. Patients may not receive concurrent treatment with any other investigational drug while on this protocol.

7. Patients must have measurable or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST).

8. Absolute granulocyte count of > 1,500/mm3 and a platelet count > 100,000/mm3.

9. Patients must have adequate liver and renal function defined by a bilirubin of ≤ 2.0 mg/dl, and a creatinine of ≤ 1.5 mg/dl respectively.

10. Patients must be able to stay in the general area for the duration of their treatment on this clinical research study.

11. Men and women who are fertile must use adequate contraception. Premenopausal women must have a negative pregnancy test documented prior to study entry.

12. Patients must be disease-free of prior invasive malignancies for >= 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

Exclusion Criteria:

Individuals excluded from participating in this study are described below.

1. Women who are pregnant or breast-feeding

2. Patients with clinical signs of brain involvement or leptomeningeal disease.

3. Patients with progressive sensory neuropathy or progressive hearing loss or tinnitus.

4. Patients with other serious illness or medical conditions, including but not limited to the following:

• congestive heart failure or angina pectoris

• previous history of myocardial infarction within 1 year from study entry

• uncontrolled hypertension or arrhythmias

• active infections

• unstable diabetes mellitus