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Erlotinib in Treating Patients With Advanced Kidney Cancer
This study has been completed.
Sponsors and Collaborators: Institute for Drug Development
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00045487
  Purpose

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have advanced kidney cancer.


Condition Intervention Phase
Kidney Cancer
Drug: erlotinib hydrochloride
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Erlotinib Erlotinib hydrochloride Tyrosine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II, Pharmacokinetic And Biologic Correlative Study Of OSI-774, An EGFR Tyrosine Inhibitor, In Patients With Advanced Renal Cell Carcinoma

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

Study Start Date: June 2002
Detailed Description:

OBJECTIVES:

  • Determine the antitumor activity of erlotinib in patients with advanced renal cell carcinoma.
  • Evaluate the safety and tolerability, in terms of the toxicity profile, of this drug in these patients.
  • Determine the biologic activity of this drug, in terms of early disease progression, progression-free survival, 12-month survival rate, and overall survival, in these patients.
  • Determine the pharmacodynamics of this drug in these patients.
  • Analyze the postreceptor effects of epidermal growth factor receptor-tyrosinase kinase inhibition by this drug on cell cycle, apoptosis, and angiogenesis in tumor biopsies from these patients.
  • Correlate changes in biological measurements with indices of outcome in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 4 weeks for 52 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 19-40 patients will be accrued for this study within 8-10 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 renal cell carcinoma (RCC)

    • Papillary RCC allowed only with immunohistochemical evidence of 2+ or 3+ epidermal growth factor receptor (EGFR) expression
    • Refractory to interleukin-2 (IL-2) or interferon-based therapy OR
    • Newly diagnosed, untreated disease in patients who are not candidates for IL- 2-based treatment
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Tumor blocks available for EGFR expression analysis
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-2 OR
  • Karnofsky 70-100%

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.0 g/dL

Hepatic

  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)

Renal

  • Creatinine no greater than 1.5 times ULN OR
  • Creatinine clearance greater than 60 mL/min
  • Corrected calcium less than 12.0 mg/dL

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Opthalmic

  • No abnormalities of the cornea (e.g., dry eye syndrome or Sjogren's syndrome)
  • No congenital abnormalities (e.g., Fuch's dystrophy)
  • No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
  • No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)

Gastrointestinal

  • No gastrointestinal tract disease resulting in an inability to take oral medications or a requirement for IV alimentation
  • No active peptic ulcer disease

Other

  • No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast
  • No prior allergic reactions to compounds of similar chemical or biological composition to erlotinib
  • No other uncontrolled concurrent illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study participation
  • No significant traumatic injury within the past 21 days
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • Concurrent epoetin alfa allowed

Chemotherapy

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered

Surgery

  • Prior nephrectomy or resection of metastatic lesions allowed
  • At least 21 days since prior major surgery
  • Recovered from prior surgery
  • No prior surgical procedures affecting absorption

Other

  • No prior EGFR-targeting therapies
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent antitumor therapies
  • Concurrent bisphosphonates allowed
  • Concurrent hypocalcemic agents allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045487

Locations
United States, Texas
San Antonio Cancer Institute
San Antonio, Texas, United States, 78229-3264
Sponsors and Collaborators
Institute for Drug Development
Investigators
Study Chair: Anthony W. Tolcher, MD San Antonio Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000256598, SACI-IDD0127, NCI-5410
Study First Received: September 6, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00045487  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer

Study placed in the following topic categories:
Erlotinib
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Recurrence
Carcinoma
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009