Combination Chemotherapy In Treating Patients With Recurrent, Refractory, Or Metastatic Solid Tumors Or Lymphomas

Study Overview

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.

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.

Colorectal Cancer
Esophageal Cancer
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Liver Cancer
Lung Cancer
Lymphoma
Pancreatic Cancer
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific

DRUG: fluorouracil
DRUG: gemcitabine hydrochloride
DRUG: leucovorin calcium

980143
98-C-0143
CDR0000066587

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2001-07-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-03-21
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-03-23
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2012-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

ECOG 0-2

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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Eva Szabo, MD, National Cancer Institute (NCI)

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Wright MA, Schuler B, Szabo E, Grem JL. Sustained partial response of an intra-abdominal desmoid tumor treated with gemcitabine, 5-fluorouracil and leucovorin. Ann Oncol. 2003 Apr;14(4):659-60. doi: 10.1093/annonc/mdg155. No abstract available.

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Clinical Trial Record