Study of Polyphenon E in Addition to Erlotinib in Advanced Non Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to study if the addition of the green tea extract, Polyphenon E, to Erlotinib is safe and if it has potential to improve outcomes in second line therapy for Advanced Stage IIIb/IV Non-small cell lung cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Louisiana State University Health Sciences Center Shreveport
• Collaborator: Polyphenon E International,Inc.
• Treatments: Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

1. Biopsy proven NSCLC

2. Stage IIIB or IV measurable disease burden after routine staging work up.

3. Documented disease progression after first or second line chemotherapy. This will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST)

4. Ability to give informed consent and willingness to adhere to study protocol

5. Ability to take oral medication

6. Age ≥ 18 years.

7. Eastern Cooperative Oncology Group (ECOG) Performance Status between 0-2

8. Adequate hematological, hepatic and renal function defined as below:

granulocyte count > 1500/mm3, platelet count > 100.000/mm3, serum creatinine < 1.5; bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) at or below institutional upper limit of normal (IULN). All lab values should be obtained within 14 days of registration.

9. Patients have to have recovered from any toxic effects of prior chemotherapy or radiation therapy to a Grade 1 or less (except from alopecia). Enrollment should occur no less than 28 days after completion of prior therapy.

10. Ability to comply with the use of contraceptive measures starting 1 week before and ending 2 weeks after the last dose of study drug.

Exclusion Criteria:

1. Liver or kidney problems that would interfere with metabolism of study drug. This includes any preexisting elevation of AST, ALT, ALP or bilirubin.

2. Any condition that would hamper informed consent or ability to comply with the study protocol

3. Participation in another research study in the last three months

4. Known malignancy at any site other than NSCLC

5. Recent consumption of green tea (5 or more cups per day within one week of study enrollment)

6. Significant history of cardiac disease, e.g. uncontrolled hypertension, unstable angina, congestive-heart failure, myocardial infarction within the last six months or ventricular arrhythmias requiring medication.

7. Presence of metastatic brain lesions

8. Documented history of bleeding diathesis

9. Need to be on therapeutic anticoagulation

10. Pregnant and lactating women

11. Patients with a known seizure disorder who are taking Phenytoin, Carbamazepine or Phenobarbital

12. Patients taking medications known to interfere with erlotinib metabolism as listed below.

• Atazanavir

• Clarithromycin

• Indinavir

• Itraconazole

• Ketoconazole

• Nefazodone

• Nelfinavir

• Ritonavir

• Saquinavir

• Telithromycin

• Troleandomycin

• Voriconazole

• Rifampicin

• Rifabutin

• Rifapentine

• Phenytoin

• Carbamazepine

• Phenobarbital

• St John's Wort.