NCT00003331

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 topotecan, fluorouracil, and leucovorin in treating patients who have advanced cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

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

January 1, 1998

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2001

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

September 13, 2004

Completed
Last Updated

March 28, 2011

Status Verified

March 1, 2011

Enrollment Period

3.8 years

First QC Date

November 1, 1999

Last Update Submit

March 25, 2011

Conditions

Chronic Myeloproliferative DisordersLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesPrecancerous ConditionUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomamonoclonal gammopathy of undetermined significancerecurrent adult Hodgkin lymphomaisolated plasmacytoma of boneextramedullary plasmacytomarefractory multiple myelomaWaldenstrom macroglobulinemiastage III multiple myelomastage IV chronic lymphocytic leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiarefractory chronic lymphocytic leukemiaunspecified adult solid tumor, protocol specificchronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiameningeal chronic myelogenous leukemiauntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemiaadult acute myeloid leukemia in remissionadult acute lymphoblastic leukemia in remissionpolycythemia veraprimary myelofibrosisessential thrombocythemiauntreated hairy cell leukemiaprogressive hairy cell leukemia, initial treatmentrefractory hairy cell leukemiachronic myelomonocytic leukemiaT-cell large granular lymphocyte leukemiaacute undifferentiated leukemiastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage 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 III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomasecondary acute myeloid leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesprolymphocytic leukemiaAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaprimary systemic amyloidosisstage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone 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 lymphoma

Interventions

fluorouracilDRUG
leucovorin calciumDRUG
topotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven advanced malignancy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL SGOT less than 3 times upper limit of normal (ULN) (less than 5 times ULN if due to hepatic metastases) LDH less than 3 times ULN (less than 5 times ULN if due to hepatic metastases) Alkaline phosphatase less than 3 times ULN (less than 5 times ULN if due to hepatic metastases) Renal: Creatinine no greater than 1.5 mg/dL Other: No active infection requiring systemic therapy within 1 week prior to entry No significant concurrent illness No history of bleeding disorder or clotting factor deficiency No dementia or altered mental status that would prohibit informed consent Not pregnant or nursing Effective contraception strongly advised for fertile women PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors during topotecan infusion Chemotherapy: At least 3 weeks since prior chemotherapy No more than 3 prior chemotherapy regimens Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (1)

Kaplan Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesPrecancerous ConditionsHodgkin DiseaseMonoclonal Gammopathy of Undetermined SignificanceWaldenstrom MacroglobulinemiaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisPolycythemia VeraPrimary MyelofibrosisThrombocythemia, EssentialLeukemia, Hairy CellLeukemia, Myelomonocytic, ChronicLeukemia, Large Granular LymphocyticLeukemia, Biphenotypic, AcuteLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, ProlymphocyticImmunoglobulin Light-chain AmyloidosisLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticLymphoma, B-Cell, Marginal Zone

Interventions

FluorouracilLeucovorinTopotecan

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersHypergammaglobulinemiaLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesBone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersMyelodysplastic-Myeloproliferative DiseasesLeukemia, T-CellLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesLymphadenopathyLymphoma, T-Cell

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesCamptothecinAlkaloids

Study Officials

  • Howard S. Hochster, MD

    NYU Langone Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 13, 2004

Study Start

January 1, 1998

Primary Completion

November 1, 2001

Last Updated

March 28, 2011

Record last verified: 2011-03

Locations

US(1)