NCT00005842

Brief Summary

Phase I trial to study the effectiveness of trastuzumab plus R115777 in treating patients who have advanced or metastatic cancer. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with R115777 may kill more tumor cells.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 cancer

Geographic Reach
1 country

2 active sites

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

June 1, 2000

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 26, 2004

Completed
Last Updated

February 11, 2013

Status Verified

April 1, 2007

Enrollment Period

3.7 years

First QC Date

June 2, 2000

Last Update Submit

February 8, 2013

Conditions

Cancer

Keywords

stage III colon cancerstage IV colon cancerstage IV breast cancerstage IIIA breast cancerrecurrent breast cancerstage III gastric cancerstage IV gastric cancerrecurrent gastric canceroccult non-small cell lung cancerstage IIIB breast cancerrecurrent non-small cell lung cancerstage III pancreatic cancerrecurrent pancreatic cancerstage III rectal cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancerstage IV anal cancerrecurrent anal cancerstage III esophageal cancerstage IV esophageal cancerstage IIIA anal cancerstage IIIB anal cancerrecurrent esophageal cancerstage III cervical cancerrecurrent cervical cancerstage IVB cervical cancerstage IVA cervical cancerinflammatory breast cancerstage III renal cell cancerstage IV renal cell cancerrecurrent renal cell cancermetastatic parathyroid cancerrecurrent parathyroid cancerstage III vulvar cancerstage IVB vulvar cancerrecurrent vulvar cancerstage III vaginal cancerstage IVA vaginal cancerstage IVB vaginal cancerrecurrent vaginal cancermetastatic gastrointestinal carcinoid tumorrecurrent gastrointestinal carcinoid tumorlocalized unresectable adult primary liver canceradvanced adult primary liver cancerrecurrent adult primary liver cancergastrinomastage III endometrial carcinomastage IV endometrial carcinomarecurrent endometrial carcinomasmall intestine adenocarcinomaunresectable gallbladder cancerrecurrent gallbladder cancerunresectable extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancerrecurrent small intestine cancerstage III adrenocortical carcinomastage IV adrenocortical carcinomarecurrent adrenocortical carcinomastage III bladder cancerrecurrent bladder cancerstage IV bladder cancerstage III malignant testicular germ cell tumorstage III prostate cancerstage IV prostate cancerrecurrent prostate cancerrecurrent malignant testicular germ cell tumorinsulinomarecurrent islet cell carcinomastage IV papillary thyroid cancerstage IV follicular thyroid cancerthyroid gland medullary carcinomaanaplastic thyroid cancerrecurrent thyroid cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerstage III salivary gland cancerstage IV salivary gland cancerrecurrent salivary gland cancerWDHA syndromesomatostatinomapancreatic polypeptide tumorglucagonomastage III follicular thyroid cancerstage III papillary thyroid cancerrecurrent urethral cancerdistal urethral cancerproximal urethral cancerurethral cancer associated with invasive bladder cancermetastatic transitional cell cancer of the renal pelvis and ureterpulmonary carcinoid tumorstage III mucoepidermoid carcinoma of the oral cavitystage III adenoid cystic carcinoma of the oral cavitystage IV mucoepidermoid carcinoma of the oral cavitystage IV adenoid cystic carcinoma of the oral cavityrecurrent mucoepidermoid carcinoma of the oral cavityrecurrent adenoid cystic carcinoma of the oral cavitytumors metastatic to brainlung metastasesliver metastasesbone metastasesskin metastasesleptomeningeal metastasesmalignant pericardial effusionmalignant pleural effusionnewly diagnosed carcinoma of unknown primaryrecurrent transitional cell cancer of the renal pelvis and uretercarcinoma of the appendixprimary peritoneal cavity cancerrecurrent carcinoma of unknown primarymale breast cancerstage IV pancreatic cancer

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive trastuzumab (Herceptin) IV over 90 minutes on days 1, 8, 15, and 22 plus oral R115777 twice daily for 3 weeks. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities.

Biological: trastuzumabDrug: tipifarnib

Interventions

trastuzumabBIOLOGICAL
Arm I
tipifarnibDRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced or metastatic adenocarcinoma * Expression of +1 to 3+ HER2/neu on immunohistochemical or immunocytochemistry staining * No brain metastases unless all of the following is true: * Previously treated * Asymptomatic * Stable dose of decadron * No evidence of edema PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: ECOG 0-2 * Life expectancy: At least 12 weeks * Absolute granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 9.0 g/dL * Bilirubin no greater than 1.5 mg/dL * AST/ALT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN in case of liver involvement) * Creatinine no greater than 1.5 mg/dL * LVEF at least 50% by RVG or MUGA * No uncontrolled unstable angina * No history of congestive heart failure or cardiac ischemia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No concurrent active infection or serious systemic disorder that would preclude study * No allergies to imidazole compounds PRIOR CONCURRENT THERAPY: * No prior trastuzumab (Herceptin) No other concurrent immunotherapy * At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) and recovered * No other concurrent chemotherapy * No concurrent hormonal cancer therapy except LHRH agonists for prostate cancer * No concurrent radiotherapy * No other concurrent experimental medications

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

Sponsors & Collaborators

Study Sites (2)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Institute for Drug Development

San Antonio, Texas, 78245-3217, United States

Location

Related Publications (1)

  • Schwartz G, Rowinsky EK, Rha SY, et al.: A phase I, pharmacokinetic, and biologic correlative study of R115777 and trastuzumab (herceptin) in patients with advanced cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-322, 2001.

    RESULT

MeSH Terms

Conditions

NeoplasmsColonic NeoplasmsBreast NeoplasmsStomach NeoplasmsCarcinoma, Non-Small-Cell LungPancreatic NeoplasmsRectal NeoplasmsAnus NeoplasmsEsophageal NeoplasmsUterine Cervical NeoplasmsInflammatory Breast NeoplasmsCarcinoma, Renal CellParathyroid NeoplasmsVulvar NeoplasmsVaginal NeoplasmsCarcinoma, HepatocellularGastrinomaEndometrial NeoplasmsGallbladder NeoplasmsBile Duct NeoplasmsAdrenocortical CarcinomaUrinary Bladder NeoplasmsTesticular NeoplasmsProstatic NeoplasmsInsulinomaCarcinoma, Islet CellThyroid Cancer, PapillaryAdenocarcinoma, FollicularCarcinoma, MedullaryThyroid Carcinoma, AnaplasticThyroid NeoplasmsSalivary Gland NeoplasmsVipomaSomatostatinomaGlucagonomaUrethral NeoplasmsBrain NeoplasmsMeningeal CarcinomatosisPleural Effusion, MalignantAppendiceal NeoplasmsNeoplasms, Unknown PrimaryBreast Neoplasms, Male

Interventions

Trastuzumabtipifarnib

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesStomach DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesRectal DiseasesAnus DiseasesHead and Neck NeoplasmsEsophageal DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsKidney DiseasesUrologic DiseasesMale Urogenital DiseasesParathyroid DiseasesVulvar DiseasesVaginal DiseasesLiver NeoplasmsLiver DiseasesBiliary Tract NeoplasmsBiliary Tract DiseasesGallbladder DiseasesBile Duct DiseasesAdrenal Cortex NeoplasmsAdrenal Gland NeoplasmsAdrenal Cortex DiseasesAdrenal Gland DiseasesUrinary Bladder DiseasesGenital Neoplasms, MaleGenital Diseases, MaleTesticular DiseasesGonadal DisordersProstatic DiseasesAdenoma, Islet CellAdenomaAdenocarcinoma, PapillaryThyroid DiseasesCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve TissueMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesUrethral DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMeningeal NeoplasmsPleural NeoplasmsPleural EffusionPleural DiseasesCecal NeoplasmsCecal DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Anthony W. Tolcher, MD

    San Antonio Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2000

First Posted

April 26, 2004

Study Start

June 1, 2000

Primary Completion

February 1, 2004

Last Updated

February 11, 2013

Record last verified: 2007-04

Locations

US(2)