Combination Chemotherapy in Treating Patients With Recurrent, Refractory, or Metastatic Solid Tumors or Lymphomas

• Status: Completed
• Trial end date: 2004-06-01
• 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 combining gemcitabine, fluorouracil, and leucovorin in treating patients with recurrent, refractory, or metastatic solid tumors or lymphomas.

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

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Calcium; Calcium, Dietary; Fluorouracil; Gemcitabine; Leucovorin; Levoleucovorin

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of cancer that has failed standard therapy or for which no such therapy exists, including, but not limited to:

• Unresectable primary or recurrent solid tumors (e.g., colon, pancreatic, lung, esophageal, or cholangiocarcinoma)

• Metastatic disease

• Lymphoma with no prior high-dose chemotherapy requiring autologous or allogeneic stem cell rescue

• No leukemias

• No CNS metastases or primary CNS malignancies

• No failure on prior gemcitabine therapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute granulocyte count at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

• Transaminases less than 6 times upper limit of normal

Renal:

• Creatinine no greater than 2.0 mg/dL

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other serious concurrent medical illness that would preclude study

• No active infections requiring IV antibiotics

• HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

• More than 4 weeks since prior immunotherapy and recovered

Chemotherapy:

• See Disease Characteristics

• More than 4 weeks since prior chemotherapy (at least 6 weeks for mitomycin or nitrosoureas) and recovered

• At least 3 months since prior suramin

• At least 5 weeks since prior eniluracil (8 weeks prior to start of fluorouracil) and recovered

Endocrine therapy:

• No steroid therapy if utilized for chronic lymphoma therapy

• At least 4 weeks since prior steroidal therapy as disease treatment

Radiotherapy:

• At least 2 weeks since prior radiotherapy to no more than 20% of bone marrow

• At least 4 weeks since prior radiotherapy to 21% or more of bone marrow

• Recovered from prior radiotherapy

Surgery:

• Recovered from prior surgery

Other:

• No concurrent cimetidine