Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors

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

Summary

Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or unresectable solid tumors. 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.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Fluorouracil; Gemcitabine; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically or clinically confirmed metastatic or unresectable solid tumor for which no standard curative or palliative therapy exists or is no longer

• No known brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin normal

• Proven Gilbert's syndrome (UGT1A1 promoter mutation or clinical

• documentation of stress bilirubin levels) allowed

• AST/ALT no greater than 3 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

Pulmonary:

• No unexplained respiratory problems (e.g., nonproductive cough, dyspnea,

• rales, pulmonary infiltrates, hypoxia, or tachypnea)

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No clinical evidence of neuropathy

• No prior allergy to platinum compounds

• No prior allergy to antiemetics appropriate for administration in

• conjunction with protocol directed chemotherapy

• No other concurrent uncontrolled illness (e.g., active infection)

PRIOR CONCURRENT THERAPY:

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and

• platinum) and recovered

• No more than 1 prior chemotherapy regimen for cancer

Radiotherapy:

• At least 4 weeks since prior radiotherapy

Other:

• No concurrent antiretroviral agents (HAART)

• No other concurrent investigational agents or commercial therapies