Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2005-02-01
• 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 combination chemotherapy in treating patients who have advanced solid tumors.

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

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Gemcitabine; Liposomal doxorubicin; Vinblastine; Vinorelbine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed solid tumor not amenable to curative surgery, radiotherapy, or chemotherapy

• No brain metastases or primary brain tumors

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• WBC at least 3,500/mm3

• Absolute neutrophil count at least 1,500/mm3

• Platelet count at least 100,000/mm3

• Hemoglobin greater than 10 g/dL

Hepatic:

• Bilirubin no greater than 1.2 mg/dL

• AST and/or ALT less than 2.5 times upper limit of normal (ULN)

• PT no greater than ULN (anticoagulant independent)

Renal:

• Creatinine no greater than 1.5 mg/dL AND/OR

• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• No New York Heart Association class III or IV heart disease

• LVEF at least 45% by MUGA or echocardiogram

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior bone marrow or peripheral blood stem cell transplantation following high dose chemotherapy

• At least 3 weeks since prior biologic therapy for cancer and recovered

• No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy:

• See Disease Characteristics

• See Biologic therapy

• No more than 1 prior chemotherapy regimen

• No prior vinca alkaloids

• Prior anthracycline allowed if total dose no greater than 300 mg/m2

• At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or carmustine) and recovered

Endocrine therapy:

• At least 3 weeks since prior endocrine therapy for cancer and recovered

Radiotherapy:

• See Disease Characteristics

• No more than 1 prior radiotherapy regimen

• At least 4 weeks since prior large field radiotherapy

• At least 3 weeks since prior radiotherapy for cancer and recovered

Surgery:

• Not specified