Clinical trial NCT01505413: Phase 2 Study of Erlotinib, Gemcitabine and Oxaliplatin Combination Chemotherapy to Advanced Pancreatic Cancer
Official title: Phase 2 Study of GEMOX-T in Previously Untreated Patients With Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: advanced unresectable or metastatic Pancreatic Cancer
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2012-01-06
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Erlotinib is an orally available, reversible tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR). Association of chemoresistance with the activity of certain tyrosine kinases (e.g. ErbB-1 and Src) has been described for pancreatic cancer and makes a strong case for combining gemcitabine with tyrosine kinase inhibitors. In a phase III trial, the addition of erlotinib to gemcitabine improved survival compared with gemcitabine alone in advanced pancreatic cancer (MJ Moor et al). Also, gemcitabine in combination with oxaliplatin is superior to gemcitabine alone in terms of progression free survival and response rate in one phase III trial (Louvet et al). Taken together, combining erlotinib with gemcitabine and oxaliplatin may further improve the overall survival and clinical benefit of advanced pancreatic cancer.

Detailed description: Open, uncontrolled, multicenter, phase II study

This study will enroll previous chemo-naïve patients with locally advanced unresectable or metastatic pancreatic cancer.

Study regimen:

* Erlotinib 100 mg po qd daily AND
* Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1
* Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2 Every 2 weeks

Each two weeks is a cycle. If at end of 12 cycles response continues, will administer Gemcitabine and erlotinib until progression.

Eligibility criteria: Inclusion Criteria:

1. Age over 18 years
2. ECOG performance status of ≤2
3. Histologically confirmed adenocarcinoma of the pancreas
4. The disease is Locally advanced deemed by the surgeon to be unresectable, or metastatic disease.
5. Prior chemotherapy is not permitted, except for fluorouracil given concurrently as a radiosensitizer.
6. Patients must have normal organ function evidenced by

   * Number of absolute neutrophil counts (ANC) \> 1.5 x 109/L
   * Number of thrombocytes \> 100 x 109/L
   * Total bilirubin \< 1.5 x upper limit of normal (although patients with a Total bilirubin count between 1.5 and 3 x upper limit of normal in whom a decrease is anticipated, ex. Biliary stent insertion)ALAT, ASAT \< 3 x upper limit of normal (in case of liver metastasis, 5 x upper limit of normal)
   * Alkaline phosphatase \< 3 x upper limit of normal (in case of liver metastasis, 5 x upper limit of normal)
7. Pain should be controlled for at least two weeks without an increase in the narcotic consumption.
8. Biliary obstruction should be controlled for at least two weeks evident by stable or improving liver function tests especially total bilirubin.
9. Patient has signed a Patient Informed Consent Form.
10. For all females of childbearing potential, a negative pregnancy test must be obtained within 72 hours before starting therapy.
11. Is able to take medications orally
12. A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in spiral CT or multidetector CT (MD CT) or 20 mm or longer in conventional CT (it should be used by a consistent method during the study period)

Exclusion Criteria:

1. Tumor type other than adenocarcinoma
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. Symptomatic peripheral sensory neuropathy (NCI CTCAE v3.0 ≥ grade 2)
9. Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection
10. Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks before being included in the study.

Primary outcomes:
measure: Response rate
timeFrame: 24 months (01/2011 and end of study 01/2013)
Secondary outcomes:
measure: disease control rate(SD,PR,CR)
timeFrame: 24 months (01/2011 and end of study 01/2013)
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
state: Gyeonggi
Study officials:
affiliation: Soonchunhyang University Hospital
name: Kyu Taek Lee, Dr
role: STUDY_DIRECTOR
affiliation: Soonchunhyang University Hospital
name: Hee Sook Park, Dr
role: STUDY_DIRECTOR
affiliation: Soonchunhyang University Hospital
name: Dae Sik Hong, Dr
role: STUDY_DIRECTOR
References: