Oxaliplatin, Gemcitabine, and Erlotinib Study in Patients With Advanced Chemo-naïve Pancreatic Cancer

• Status: Terminated
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if the combination of Gemcitabine, Oxaliplatin and Erlotinib in the treatment of patients with pancreatic cancer will provide increased clinical benefits and improvement in their quality of life.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Guard Health Affairs
• Treatments: Erlotinib Hydrochloride; Gemcitabine; Oxaliplatin

Criteria

Inclusion Criteria:

1. Patient's age between 18 and 75 years.

2. Presence of microscopic diagnosis of pancreatic cancer.

3. The disease is Locally advanced deemed by the surgeon to be unresectable, or metastatic disease.

4. Karnofsky Performance status >50%.

5. Prior radiotherapy for local diseases is allowed provided disease progression had been documented, and treatment completed at least 4 weeks before random assignment

6. Prior chemotherapy is not permitted, except for fluorouracil given concurrently as a radiosensitizer.

7. Patients must have normal organ function evidenced by

• Cr <1.5 ULN

• ANC >1000

• platelets> 100,000

• total bilirubin <1.5ULN.

8. Pain should be controlled for at least two weeks without an increase in the narcotic consumption.

9. Biliary obstruction should be controlled for at least two weeks evident by stable or improving liver function tests especially total bilirubin.

10. Patient has signed a Patient Informed Consent Form.

11. For all females of childbearing potential, a negative pregnancy test must be obtained within 72 hours before starting therapy.

Exclusion Criteria:

1. Contraindication to chemotherapy.

2. Evidence of uncontrolled CNS disease (patients with controlled CNS disease for 4 weeks using the same imaging method and for whom are off steroid will be eligible)

3. Uncontrolled Nausea and Vomiting

4. Diagnosis of other malignancy in the last 5 years excluding non-melanoma skin cancer and in -situ cervical cancer.

5. Subjects unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow- up visits and unlikelihood of completing the study.

6. Any known history of hypersensitivity to the study drugs.

7. Pregnant or lactating women.

8. Participation in a clinical trial with any investigational drug used with curative intent and within 30 days prior to study entry

9. Peripheral sensitive neuropathy with functional impairment prior to study entry.