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Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer
This study has been completed.
First Received: June 2, 2000   Last Updated: August 29, 2009   History of Changes
Sponsor: University of Texas
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005842
  Purpose

RATIONALE: 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.

PURPOSE: Phase I trial to study the effectiveness of trastuzumab plus R115777 in treating patients who have advanced or metastatic cancer.


Condition Intervention Phase
Cancer
Biological: trastuzumab
Drug: tipifarnib
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I, Pharmacokinetic, and Biologic Correlative Study of R115777 (NSC 702818) and Herceptin in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
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.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study over 24 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 Hormonal receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: 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) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: LVEF at least 50% by RVG or MUGA No uncontrolled unstable angina No history of congestive heart failure or cardiac ischemia Other: 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: Biologic therapy: No prior trastuzumab (Herceptin) No other concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal cancer therapy except LHRH agonists for prostate cancer Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent experimental medications

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005842

Locations
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Institute for Drug Development
San Antonio, Texas, United States, 78245-3217
Sponsors and Collaborators
University of Texas
Investigators
Study Chair: Anthony W. Tolcher, MD San Antonio Cancer Institute
  More Information

Additional Information:
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.

Study ID Numbers: CDR0000067858, UTHSC-IDD-99-26, SACI-IDD-99-26, NCI-62
Study First Received: June 2, 2000
Last Updated: August 29, 2009
ClinicalTrials.gov Identifier: NCT00005842     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III colon cancer
stage IV colon cancer
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage III gastric cancer
stage IV gastric cancer
recurrent gastric cancer
occult non-small cell lung cancer
stage IIIB breast cancer
recurrent non-small cell lung cancer
stage III pancreatic cancer
recurrent pancreatic cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
stage IV anal cancer
recurrent anal cancer
stage III esophageal cancer
stage IV esophageal cancer
stage IIIA anal cancer
stage IIIB anal cancer
recurrent esophageal cancer
stage III cervical cancer
recurrent cervical cancer
stage IVB cervical cancer
stage IVA cervical cancer
inflammatory breast cancer
stage III renal cell cancer

Additional relevant MeSH terms:
Antineoplastic Agents
Therapeutic Uses
Trastuzumab
Pharmacologic Actions
Tipifarnib

ClinicalTrials.gov processed this record on November 27, 2009