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OpenTrials
Completed

NCT Number: NCT00019513

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

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.

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Key information

Conditions

Colorectal Cancer Adenocarcinoma Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Bronchial Neoplasms Burkitt Lymphoma Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Chronic Disease Colonic Diseases Colonic Neoplasms Colorectal Neoplasms DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Epstein-Barr Virus Infections Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Extrahepatic Bile Duct Cancer Gallbladder Cancer Gallbladder Diseases Gallbladder Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Infections Intestinal Diseases Intestinal Neoplasms Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Mycosis Fungoides Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Sezary Syndrome Small Cell Lung Carcinoma Small Intestine Cancer Thoracic Neoplasms Tumor Virus Infections Unspecified Adult Solid Tumor, Protocol Specific Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

About this study

OBJECTIVES:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluorouracil

Drug

gemcitabine hydrochloride

Drug

leucovorin calcium

Drug

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Phase I Study of Weekly Gemcitabine in Combination With Infusional 5-Fluorouracil and Oral Calcium Leucovorin in Adult Cancer Patients

Important dates

Study start
1998
Study completion
2004
First posted
Jan 27, 2003
Registry last updated
Mar 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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