Overview

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