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

NCT00060307 | Completed Phase 2

• 4 other identifiers: NCI-2012-03059S0317U10CA032102CDR0000301594
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well erlotinib works in treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth

Conditions

Recurrent Renal Cell Cancer; Stage III Renal Cell Cancer; Stage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

• Response probability (confirmed complete and partial response)

  Up to 3 years

Secondary Outcomes (2)

• Time to treatment failure

  6 months

• Overall survival

  6 months

Study Arms (1)

Treatment (erlotinib hydrochloride)

EXPERIMENTAL

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

Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis

Interventions

erlotinib hydrochloride DRUG

Given orally

Also known as: CP-358,774, erlotinib, OSI-774

Treatment (erlotinib hydrochloride)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (erlotinib hydrochloride)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed papillary histology renal cell carcinoma which is metastatic (M1); patients with unresectable primary tumor (but M0) are also eligible; patients who have undergone a prior nephrectomy should have histologic confirmation of the metastatic nature of at least one distant site of disease
• Patients must have available and be willing to submit representative slides for central pathology review; these must be sent within 28 days of registration; failure to submit these materials will make the patient ineligible for this study
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension; soft tissue disease that has been radiated in the 2 months prior to registration is not assessable as measurable disease; soft tissue disease within a prior radiation field that was radiated greater than 2 months prior to registration must have progressed to be considered assessable, and patients also must have measurable disease outside of the irradiated field; X-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; X-rays, scans or physical examinations for non-measurable disease must have been completed within 42 days prior to registration
• Patients with metastatic disease who have a resectable primary tumor and are deemed a surgical candidate may have undergone resection and have recovered from surgery; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery
• Patients with a history of brain metastases or who currently have treated or untreated brain metastases are not eligible; patients with clinical evidence of brain metastases must have a brain CT or MRI negative for metastatic disease within 56 days prior to registration
• Patients must have available and be willing to submit archived tumor tissue that will yield sixteen 5 micron unstained slides for molecular correlative studies related to the EGFR and vHL pathways
• Patients must not have received prior chemotherapy or immunotherapy
• Patients may have received prior radiation therapy, but must have measurable disease outside the radiation port; at least 21 days must have elapsed since completion of prior radiation therapy; patients must have recovered from all associated toxicities at the time of registration
• Patients must have a Zubrod performance status of 0 - 2
• WBC ≥ 3,000/μl obtained within 14 days prior to registration
• ANC ≥ 1,500/μl obtained within 14 days prior to registration
• Platelet count ≥ 100,000/μl obtained within 14 days prior to registration
• Serum bilirubin ≤ 1.5 x institutional upper limits of normal
• Serum transaminase (SGOT or SGPT) must be ≤ 1.5 x the institutional upper limit of normal unless the liver is involved with the tumor, in which case serum transaminase (SGOT or SGPT) must be ≤ 5 x the institutional upper limit of normal; these tests must be obtained within 14 days prior to registration
• Serum creatinine must be ≤ 2 X the institutional upper limit of normal

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Southwest Oncology Group

San Antonio, Texas, 78245, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Michael Gordon

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2003
• First Posted: May 7, 2003
• Study Start: May 1, 2003
• Primary Completion: May 1, 2007
• Last Updated: February 28, 2013

Record last verified: 2013-02

Locations

US (1)