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

Phase 2
18 Years
75 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

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

Treatment Plan GEMOX-Erlotinib consists of erlotinib 100 mg orally daily starting day 1,
Gemcitabine 1000 mg/m2 in 10 mg/m2/min (100 minutes) infusion on day 1 followed on day 2 by
oxaliplatin 100 mg/m2 in a 2-hour infusion. Treatment will be repeated every 2 weeks. Each
two weeks is a cycle. Tumor response evaluation will be performed every 2 months. If tumor
progress, patient will be off study, but if the disease is stable or PR, CR obtained will
continue treatment for total of 12 cycles. If at end of 12 cycles response continues, will
administer Gemox and erlotinib till achieve maximum response. Then start Erlotinib
maintenance therapy.

Sample size: A total of 34 patients are needed assuming expected response is greater than
10% (about 27%) and a power = 80%. Fourteen patients will be treated in the first stage; if
one patient achieved PR then additional twenty patients will be enrolled in the study for a
total of 34 patients.

Statistical Methods: Response rate with 95% CI and median time to progression of disease
will be calculated. Success will be declared if the lower limit of the 95% CI of the
response rate is greater than 10%. The 95% CI of the response rate will be calculated using
exact methods. Survival curve will be estimated using Kaplan-Meier Method. Descriptive
statistics will be used to describe patient demographics, adverse events, serious adverse
events and reasons for termination. Two approaches to the efficacy and safety analyses will
be done; the ITT (intent-to-treat) for the efficacy analysis and safety. The ITT analysis
consists of patients who received at least one dose of the study drug and at least one
on-treatment measurement of the primary efficacy endpoint (overall response). The safety
analysis consists of patients who received at least one dose of the study drug and at least
one safety measurement done. A detailed description of the statistical methods, table and
listing shells will be provided in the statistical analysis (SAP) before database lock or
data transfer to the study biostatistician.

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

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (partial and complete response, stable disease, and progressive disease)

Outcome Time Frame:

Tumor response will be assessed following the induction therapy and after cycle 4,8 and at the end of the treatment.

Safety Issue:


Principal Investigator

Abdul-Rahman M Jazieh, MD,MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Guard Hospital Affairs


Saudi Arabia: Ministry of Health

Study ID:




Start Date:

January 2008

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic cancer
  • Pancreatic Neoplasms