A Study to Test the Safety and Efficacy of Erlotinib Plus Bevacizumab to Treat Advanced Thymoma and Thymic Cancer

NCT00369889 | Completed Phase 2

• 3 other identifiers: IUCRO-0148 / 0606-20AVF3891sIUCRO-0148
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the rate of response with the combination of erlotinib and bevacizumab in previously treated patients with thymoma or thymic carcinoma, and to determine potential molecular markers that may predict response to therapy in patients with thymoma or thymic carcinoma.

Conditions

Thymic Cancer; Thymoma

Keywords

Thymoma; Thymic Cancer

Outcome Measures

Primary Outcomes (1)

• To determine the objective response rate of the combination of erlotinib and bevacizumab in using RECIST.

  completion of study

Secondary Outcomes (6)

• To determine the time to progression of patients previously treated with thymoma and thymic carcinoma treated with the combination of erlotinib and bevacizumab.

  completion of study

• To determine the toxicity of the combination of erlotinib and bevacizumab in this patient population.

  completion of study

• To correlate expression of VEGF in primary tumor sample, circulating VCAM-1 and bFGF, urine VEGF levels pre-therapy with response to therapy.

  completion of study

• To assess for the effect of known (functionally accepted) variant polymorphisms in the VEGF gene on outcomes.

  completion of study

• To determine expression of phosphorylated EGFR receptor in tumor specimen

  completion of study

Interventions

bevacizumab DRUG

iv every 21 days

Also known as: avastin

Erlotinib DRUG

oral daily

Also known as: Tarceva

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed invasive, recurrent or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery in the opinion of the investigator. Original biopsy of tumor is sufficient for diagnoses unless otherwise clinically indicated.
• Patients must have measurable disease per RECIST. Note: Any scans or x-rays used to document measurable disease must be obtained within 28 days prior to registration.
• Patients must have had prior chemotherapy (no limit for prior regimens) for metastatic disease.
• Patients must not have had any form of systemic anticancer therapy within 21 days prior to being registered for protocol therapy.
• Patients receiving radiation therapy must have completed their radiation at least 21 days prior to being registered for protocol therapy, and toxicities due to radiation must have recovered to ≤ grade 1 or baseline prior to registration. Previously radiated area(s) must not be the only site of disease.
• Be at least 18 years of age at the time of consent.
• Patient's must have laboratory data as specified below within 14 days of registration to study:
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal (ULN) (unless liver metastases are present, in which case AST/ALT ≤ 5 times upper limit of normal will be acceptable).
• Total bilirubin ≤ 1.5 mg/dl.
• White blood cell (WBC) count \> 3000/mm3
• Absolute neutrophil count (ANC) ≥ 1500/mm3
• Platelets ≥ 100,000/mm3
• International normalized ration (INR) of prothrombin time ≤ 1.2, and aPTT no more than 5 seconds longer than the ULN
• Urine protein:creatinine ratio 1.0 at screening.
• Patients must not have prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers (e.g., Grade 1, TA TCC (low grade superficial bladder cancer), colonic polyp with focus of adenocarcinoma) can also be enrolled after approval from the study chair.

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Thymus Neoplasms; Thymoma

Interventions

Bevacizumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Patrick J Loehrer, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

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: August 28, 2006
• First Posted: August 30, 2006
• Study Start: August 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: June 3, 2014

Record last verified: 2014-05

Locations

US (1)