NCT00019513

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P75+ for phase_1 colorectal-cancer

Timeline
Completed

Started Aug 1998

Longer than P75 for phase_1 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1998

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

March 23, 2012

Status Verified

March 1, 2012

First QC Date

July 11, 2001

Last Update Submit

March 21, 2012

Conditions

Colorectal CancerEsophageal CancerExtrahepatic Bile Duct CancerGallbladder CancerLiver CancerLung CancerLymphomaPancreatic CancerSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomasmall intestine lymphomaunspecified adult solid tumor, protocol specificstage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaanaplastic large cell lymphomastage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromerecurrent adult primary liver canceradvanced adult primary liver canceradult primary cholangiocellular carcinomastage IV non-small cell lung cancerrecurrent non-small cell lung cancerextensive stage small cell lung cancerrecurrent small cell lung cancerrecurrent pancreatic cancerstage IV esophageal cancerrecurrent esophageal cancerrecurrent colon cancerstage IV colon cancerrecurrent gallbladder cancerunresectable gallbladder cancercholangiocarcinoma of the gallbladderunresectable extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancercholangiocarcinoma of the extrahepatic bile ductrecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomastage IV pancreatic cancer

Interventions

fluorouracilDRUG
gemcitabine hydrochlorideDRUG
leucovorin calciumDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (1)

  • 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.

    PMID: 12649120BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsEsophageal NeoplasmsBile Duct NeoplasmsGallbladder NeoplasmsLiver NeoplasmsLung NeoplasmsLymphomaPancreatic NeoplasmsHodgkin DiseaseLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Mantle-CellLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary SyndromeCarcinoma, HepatocellularCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaColonic NeoplasmsLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

FluorouracilGemcitabineLeucovorin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesHead and Neck NeoplasmsEsophageal DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesGallbladder DiseasesLiver DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesLymphoma, T-CellLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialCarcinoma, BronchogenicBronchial NeoplasmsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • Eva Szabo, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

August 1, 1998

Study Completion

June 1, 2004

Last Updated

March 23, 2012

Record last verified: 2012-03

Locations

US(1)