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

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC) Identifier:
First received: July 11, 2001
Last updated: March 21, 2012
Last verified: March 2012

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.

Condition Intervention Phase
Colorectal Cancer
Esophageal Cancer
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Liver Cancer
Lung Cancer
Pancreatic Cancer
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: fluorouracil
Drug: gemcitabine hydrochloride
Drug: leucovorin calcium
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of Weekly Gemcitabine in Combination With Infusional 5-Fluorouracil and Oral Calcium Leucovorin in Adult Cancer Patients

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 108
Study Start Date: August 1998
Study Completion Date: June 2004
Detailed Description:


  • Determine the clinical toxic effects associated with administering sequential gemcitabine followed by fluorouracil with leucovorin calcium in patients with refractory or recurrent or metastatic solid tumors or lymphomas.
  • Determine achieved steady-state plasma levels of gemcitabine and fluorouracil in these patients.
  • Determine any antitumor activity of this regimen in these patients.
  • Determine the pharmacodynamics of gemcitabine and fluorouracil in these patients.

OUTLINE: This is a dose-escalation study of fluorouracil and gemcitabine.

During the first course, patients receive gemcitabine IV over 30 minutes once weekly for 2 weeks followed by one week of rest. During subsequent courses, patients receive gemcitabine as above followed immediately by fluorouracil IV over 24 hours once weekly for 2 weeks. Patients also receive leucovorin calcium orally on days 1 and 8 and IV on days 2 and 9. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Sequential dose escalation of fluorouracil is followed by sequential dose escalation of gemcitabine. Cohorts of 3-6 patients receive escalating doses of fluorouracil and then gemcitabine until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which 2 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A maximum of 108 patients will be accrued for this study.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Absolute granulocyte count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 2.0 mg/dL
  • Transaminases less than 6 times upper limit of normal


  • Creatinine no greater than 2.0 mg/dL


  • 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


Biologic therapy:

  • See Disease Characteristics
  • More than 4 weeks since prior immunotherapy and recovered


  • 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


  • 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


  • Recovered from prior surgery


  • No concurrent cimetidine
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Please refer to this study by its identifier: NCT00019513

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Study Chair: Eva Szabo, MD National Cancer Institute (NCI)
  More Information

Publications: Identifier: NCT00019513     History of Changes
Obsolete Identifiers: NCT00001706
Other Study ID Numbers: 980143
Study First Received: July 11, 2001
Last Updated: March 21, 2012

Keywords provided by National Institutes of Health Clinical Center (CC):
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
small intestine lymphoma
unspecified adult solid tumor, protocol specific
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
stage IV adult T-cell leukemia/lymphoma
recurrent adult T-cell leukemia/lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma
anaplastic large cell lymphoma
stage IV mycosis fungoides/Sezary syndrome

Additional relevant MeSH terms:
Lung Neoplasms
Colorectal Neoplasms
Pancreatic Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Intestinal Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases processed this record on April 28, 2017