NCT00324597

Brief Summary

RATIONALE: AMG 706 may stop the growth of cancer cells by blocking blood flow to the cancer or by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving AMG 706 together with gemcitabine may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of AMG 706 when given together with gemcitabine in treating patients with advanced solid tumors or lymphoma.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1 lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
Last Updated

September 17, 2013

Status Verified

April 1, 2007

First QC Date

May 10, 2006

Last Update Submit

September 16, 2013

Conditions

Lung CancerLymphomaLymphoproliferative DisorderUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificrecurrent adult grade III lymphomatoid granulomatosisstage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage III mantle cell lymphomastage IV mantle cell lymphomastage III marginal zone lymphomastage IV marginal zone lymphomastage III small lymphocytic lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomastage III adult T-cell leukemia/lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult T-cell leukemia/lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomasplenic marginal zone lymphomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult Hodgkin lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomaWaldenström macroglobulinemiarecurrent mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromestage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Hodgkin lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult T-cell leukemia/lymphomaadenocarcinoma of the lungbronchoalveolar cell lung cancerlarge cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerrecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomastage IV small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomapost-transplant lymphoproliferative disorderrecurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

  • Incidence of dose-limiting toxicity as assessed by NCI CTCAE v3.0

  • Maximum tolerated dose as assessed by NCI CTCAE v3.0

Secondary Outcomes (4)

  • Pharmacokinetic profiles as measured by blood sampling at weeks 1, 2, 9, 13, 21, 29, 37, 45, and 49

  • Incidence of adverse events, serious adverse events, and laboratory abnormalities not defined as dose-limiting toxicities as assessed by NCI CTCAE v3.0

  • Response rate (complete and partial response) as measured by modified RECIST at weeks 12, 24, 36, 48, and 49

  • Biomarkers as measured by RNA transcript profiling and/or proteomic methods at weeks 1, 2, 4, 9, 13, 21, 29, 37, 45, 49

Interventions

gemcitabine hydrochlorideDRUG
motesanib diphosphateDRUG
pharmacological studyOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced solid tumors or lymphoma * Must have measurable disease outside a previously irradiated field OR regrowth of tumor within a previously irradiated field * Must be a candidate for gemcitabine hydrochloride treatment, in the opinion of the investigator * No untreated or symptomatic brain metastases * No tumors with direct bowel invasion * No other hematological malignancies * No non-small cell lung cancer of squamous cell histology or large central tumor (lesions ≥ 3 cm and located adjacent to or within the hilum or mediastinum) PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Not pregnant * No nursing during and for 6 months after completion of study treatment * Fertile patients must use effective contraception during and for 6 months after completion of study treatment * Negative pregnancy test * Able to swallow oral medication * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL * Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 40 mL/min * Albumin-adjusted calcium ≥ 8 mg/dL * Urine protein \< 30 mg/dL by urinalysis or \< 1+ by dipstick OR \< 500 mg by 24-hour urine collection * AST or ALT ≤ 2.5 times upper limit of normal (ULN) (5.0 times ULN in the presence of liver metastasis or primary hepatic neoplasm) * Bilirubin ≤ 2 times ULN * PT ≤ 2.0 * INR or PTT ≤ 1.5 times ULN * Systolic blood pressure (BP) ≤ 145 mm Hg and diastolic BP ≤ 85 mm Hg (stable antihypertensive medication allowed) * No myocardial infraction within the past year * No arterial thrombosis or deep vein thrombosis within the past year * No unstable angina * No congestive heart failure * No New York Heart Association class III-IV cardiac disease * No other unstable or uncontrolled disease or condition relating to or impacting cardiac function * No HIV positivity * No other condition that would preclude study participation, compliance, or follow-up assessments PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior enrollment into this study * At least 1 month since prior investigational device or drug trial * At least 1 month since prior major surgical procedure * At least 3 weeks since prior systemic chemotherapy * At least 2 weeks since prior radiotherapy * At least 2 weeks since prior rifampin or phenobarbital * At least 1 week since prior treatment with any of the following: * Ketoconazole * Itraconazole * Clarithromycin * Erythromycin * Cyclosporine or tacrolimus * Nefazodone * Herbal medications containing Hypericum perforatum (St. John's wort) * At least 1 week since prior and no concurrent warfarin * Concurrent prophylactic anticoagulation therapy (e.g., low-dose warfarin \[≤ 2 mg/day\] or low molecular weight heparin) for venous or arterial access devices allowed * No prior or concurrent kinase insert domain-receptor inhibitors * No concurrent chemotherapy, radiotherapy, hormone-directed cancer therapy, or tumor-directed antibody therapy * Gonadotropin releasing-hormone agonist therapy allowed * No concurrent interferon * No concurrent grapefruit juice or whole grapefruit * No other concurrent standard or investigational drugs or antitumor treatment, including c-kit, platelet-derived growth factor, vascular endothelial growth factor, or epidermal growth factor inhibitors * No elective surgery during or for 2 weeks after completion of the last dose of AMG 706

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

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsLymphomaLymphoproliferative DisordersLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellLymphoma, T-Cell, CutaneousPrecursor T-Cell Lymphoblastic Leukemia-LymphomaHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinWaldenstrom MacroglobulinemiaMycosis FungoidesSezary SyndromeAdenocarcinoma of LungAdenocarcinoma, Bronchiolo-AlveolarCarcinoma, Non-Small-Cell LungLymphoma, Large-Cell, AnaplasticImmunoblastic Lymphadenopathy

Interventions

Gemcitabinemotesanib diphosphate

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms by Histologic TypeLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, T-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialCarcinoma, BronchogenicBronchial NeoplasmsLymphadenopathy

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Carolyn Britten, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 11, 2006

Study Start

October 1, 2005

Last Updated

September 17, 2013

Record last verified: 2007-04

Locations

US(1)