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Erlotinib in Treating Patients With Locally Advanced or Metastatic Papillary Renal Cell Cancer
This study is ongoing, but not recruiting participants.
First Received: May 6, 2003   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00060307
  Purpose

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

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer.


Condition Intervention Phase
Kidney Cancer
Drug: erlotinib hydrochloride
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Erlotinib hydrochloride Erlotinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of OSI-774 (NSC-718781) in Patients With Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer

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

Primary Outcome Measures:
  • Response probability [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to treatment failure [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]

Study Start Date: May 2003
Detailed Description:

OBJECTIVES:

  • Determine the response (confirmed complete and partial response) in patients with locally advanced or metastatic papillary renal cell cancer treated with erlotinib.
  • Determine the overall survival and 6-month probability of treatment failure in patients treated with this drug.
  • Determine the qualitative and quantitative toxic effects of this drug in these patients.
  • Determine, preliminarily, the association of tumor response with tumor expression of epidermal growth factor receptor and status of von Hippel-Lindau gene mutation in patients treated with this drug.

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

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-20 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 papillary renal cell cancer, meeting 1 of the following stage criteria:

    • M1 (metastatic disease)
    • M0 with unresectable primary tumor
  • Prior resection of primary tumor allowed

    • Histological confirmation of at least 1 metastatic site of disease required if patients underwent nephrectomy
  • Measurable disease

    • At least 1 unidimensionally measurable lesion
    • Soft tissue disease irradiated within the past 2 months is not considered measurable disease
    • Soft tissue disease irradiated more than 2 months ago must have progressed to be considered measurable with additional measurable disease outside the radiation field
  • No prior or concurrent (treated or untreated) brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if there is liver involvement by tumor)

Renal

  • Creatinine no greater than 2 times ULN

Ophthalmic

  • No known history of any of the following corneal diseases:

    • Dry eye syndrome
    • Sjögren's syndrome
    • Keratoconjunctivitis sicca
    • Exposure keratopathy
    • Fuch's dystrophy
  • No other active disorders of the cornea

Gastrointestinal

  • No gastrointestinal tract disease resulting in an inability to take oral medication
  • No requirement for IV alimentation
  • No active peptic ulcer disease
  • Able to swallow and/or receive enteral medication via gastrostomy feeding tube
  • No intractable nausea or vomiting

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior immunotherapy

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 21 days since prior radiotherapy and recovered

Surgery

  • See Disease Characteristics
  • At least 28 days since prior surgery and recovered
  • No prior surgical procedure affecting absorption

Other

  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060307

  Show 181 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Eastern Cooperative Oncology Group
Investigators
Investigator: Michael S. Gordon, MD Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
Investigator: Primo N. Lara, MD University of California, Davis
Investigator: Janice P. Dutcher, MD Our Lady of Mercy Medical Center Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Pan C, Hussey M, Lara PN, et al.: Encouraging survival with erlotinib in advanced papillary renal cell carcinoma (pRCC): final results from Southwest Oncology Group study 0317. [Abstract] J Clin Oncol 26 (Suppl 15): A-5051, 2008.
Pan C, Hussey M, Lara P, et al.: Phase II trial of the epidermal growth factor receptor (EGFR) inhibitor erlotinib (E) in patients (pts) with advanced papillary renal cell carcinoma (pRCC): SWOG S0317. [Abstract] J Clin Oncol 25 (Suppl 18): A-15516, 651s, 2007.

Study ID Numbers: CDR0000301594, SWOG-S0317, ECOG-S0317
Study First Received: May 6, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00060307     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Erlotinib
Urinary Tract Neoplasm
Kidney Cancer
Urogenital Neoplasms
Urologic Neoplasms
Protein Kinase Inhibitors
Recurrence
Carcinoma
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Erlotinib
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Urogenital Neoplasms
Urologic Neoplasms
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009