Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Erlotinib in Treating Patients With Locally Advanced or Metastatic Papillary Renal Cell Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	SWOG-S0317 ECOG-S0317, S0317, NCT00060307

Objectives

1. Determine the response (confirmed complete and partial response) in patients with locally advanced or metastatic papillary renal cell cancer treated with erlotinib.
2. Determine the overall survival and 6-month probability of treatment failure in patients treated with this drug.
3. Determine the qualitative and quantitative toxic effects of this drug in these patients.
4. 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.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 20-40 patients will be accrued for this study within 5-20 months.

Outcomes

Response probability

Time to treatment failure
Survival

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.

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Michael Gordon, MD, Study coordinator(Contact information may not be current)		Ph: 480-323-1000
Primo Lara, MD, Study coordinator		Ph: 916-734-3771

Eastern Cooperative Oncology Group

Janice Dutcher, MD, Study coordinator		Ph: 718-304-7200

Registry Information
Official Title		A Phase II Study of OSI-774 (NSC-718781) in Patients with Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer
Trial Start Date		2003-05-01
Registered in ClinicalTrials.gov		NCT00060307
Date Submitted to PDQ		2003-03-26
Information Last Verified		2006-01-04
NCI Grant/Contract Number		CA32102

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