Erlotinib in Treating Patients With Advanced Kidney Cancer

NCT00045487 | Completed Phase 2 Results

• 3 other identifiers: CDR0000256598IDD 01-27NCI-5410
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancer; stage III renal cell cancer; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Ani-tumor Activity After Taking OSI-774.

  Antitumor activity is measured with conventional techniques such as CT, MRI or X-ray. Scans are done at baseline then evaluated for response every 2 months. All tumor measurements must be recorded millimeters (or decimal fractions of centimeters).

  Disease progression or 52 weeks duration

Study Arms (1)

OSI-774

EXPERIMENTAL

Drug: OSI-774

Interventions

OSI-774 DRUG

OSI-774 is an orally active, potent, selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase.

OSI-774

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 diagnosis of advanced renal cell carcinoma (RCC). Papillary RCC is permitted only if immunohistochemical evidence of strong (2-3+) EGFR expression.
• Disease that is recurrent or refractory to IL-2 or IFN-based therapy or new diagnosis in previously untreated patients who are not appropriate candidates to receive IL-2 -based treatment
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan.
• Prior nephrectomy or resection of metastatic lesions permitted if full surgical recovery has occurred.
• Age \> 18 years Because no dosing or adverse event data are currently available on the use of OSI-774 in patients \<18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.
• Life expectancy of at least 12 weeks
• ECOG performance status of 0,1 or 2 or Karnofsky \>60%
• Patients must have normal organ and marrow function as defined below:
• Hematopoietic
• Absolute neutrophil count at least ≥ 1,500/ul
• Platelet ≥ 100,000/uL
• Hemoglobin ≥ 9.0 g/dL, concomitant erythropoetin permitted Hepatic
• a. Total bilirubin within normal institutional limits b. AST (SGOT)/ALT (SGPT) ≤ 2.5 times institutional upper limit of normal (≤5 times ULN if liver metastases present) Renal
• a. Serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance \> 60 mL/min/1.73m2 Calcium
• a. Corrected calcium \< 12.0 mg/dl, concomitant hypocalcemic agents permitted

You may not qualify if:

• History of active malignancy (other than RCC) in the past 3 years, other than nonmelanomatous skin cancer or in situ breast cancer or in situ cervical cancer.
• Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Patients may not be receiving any other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-774.
• Prior treatment with EGFR targeting therapies.
• Inability to understand the written informed consent document.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Major surgery, or significant traumatic injury occurring within 21 days prior to treatment.
• Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogren's syndrome), congenital abnormality (e.g., Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test).
• Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease.
• Pregnant women are excluded from this study because OSI-774 is an epidermal growth factor inhibitor with the potential for teratogenic or abortifacient effects based on the data suggesting that EGFR expression is important for normal organ development. For this reason, women of childbearing potential and men must also agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OSI-774, breastfeeding should be discontinued if the mother is treated with OSI-774.
• Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with OSI-774. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
• Informed Consent - No study specific procedures will be performed without a written and signed informed consent document. Patients who do not demonstrate the ability to understand or the willingness to sign the written informed consent document are excluded from study entry.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

The PI/responsible party left this institution. Additional records for completion of results entries is not available at our institution. NCI transferred the PRS record to this institution \>4.5 years after the PIs left employment.

Results Point of Contact

• Title: Alain Mita, MD
• Organization: University of Texas Health Science Center San Antonio

goodwine@uthscsa.edu

210-450-5094

Study Officials

• Anthony W. Tolcher, MD

  University of Texas Health Science Center San Antonio

  STUDY CHAIR

• Alain Mita, MD

  Cedar Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: September 6, 2002
• First Posted: January 27, 2003
• Study Start: June 1, 2002
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: January 27, 2014
• Results First Posted: January 27, 2014

Record last verified: 2013-12

Locations

US (1)