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Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer

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ClinicalTrials.gov Identifier: NCT00005842
Recruitment Status : Completed
First Posted : April 26, 2004
Last Update Posted : February 11, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE June 2, 2000
First Posted Date  ICMJE April 26, 2004
Last Update Posted Date February 11, 2013
Study Start Date  ICMJE June 2000
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00005842 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer
Official Title  ICMJE A Phase I, Pharmacokinetic, and Biologic Correlative Study of R115777 (NSC 702818) and Herceptin in Patients With Advanced Cancer
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.
Detailed Description

OBJECTIVES:

I. Determine the maximum tolerated dose of R115777 when administered with trastuzumab (Herceptin) in patients with advanced or metastatic adenocarcinoma.

II. Assess the toxicities and pharmacokinetics of this treatment regimen in this patient population.

III. Determine the antitumor activity of this treatment regimen in these patients.

IV. Determine the relative biologic endpoints of this regimen and correlate them with toxicity and pharmacokinetic parameters in these patients.

OUTLINE: This is a dose escalation, multicenter study of R115777.

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.

Patients are followed every 30 days until toxicity resolves.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer
Intervention  ICMJE
  • Biological: trastuzumab
  • Drug: tipifarnib
Study Arms  ICMJE Experimental: Arm I
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.
Interventions:
  • Biological: trastuzumab
  • Drug: tipifarnib
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February¬†8,¬†2013)
24
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00005842
Other Study ID Numbers  ICMJE CDR0000067858
UTHSC-IDD-99-26
SACI-IDD-99-26
NCI-62
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Anthony W. Tolcher, MD San Antonio Cancer Institute
PRS Account National Cancer Institute (NCI)
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP