Combination Chemotherapy in Treating Patients With Recurrent, Refractory, or Metastatic Solid Tum… (NCT00019513) | Clinical Trial Compass
CompletedPhase 1
Combination Chemotherapy in Treating Patients With Recurrent, Refractory, or Metastatic Solid Tumors or Lymphomas
United States108 participantsStarted 1998-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 wee…
Trial details
NCT IDNCT00019513
SponsorNational Institutes of Health Clinical Center (CC)