Study of Neoadjuvant Treatment in Patients With Pancreatic Cancer That is Potentially Resectable

• ClinicalTrials.gov Identifier: NCT01531712
• Recruitment Status: Terminated
• First Posted: February 13, 2012
• Last Update Posted: August 29, 2017
• Sponsor: Institut Català d'Oncologia
• Information provided by (Responsible Party): Institut Català d'Oncologia

Tracking Information

• First Submitted Date: January 11, 2012
• First Posted Date: February 13, 2012
• Last Update Posted Date: August 29, 2017
• Study Start Date: February 10, 2011
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 14, 2012)

Resectability rate after neoadjuvant treatment with chemotherapy plus chemoradiotherapy. [ Time Frame: Two years ]

Determine the resectability rate of subjects with borderline resectable pancreatic cancer (radiologically measured) that were treated with Gemcitabine, Tarceva and Oxaliplatin followed by chemoradiotherapy with Gemcitabine and Tarceva.

Original Primary Outcome Measures (submitted: February 10, 2012)

Primary outcome measure [ Time Frame: Two years ]

Determine the resectability rate of subjects with borderline resectable pancreatic cancer (radiologically measured) that were treated with Gemcitabine, Tarceva and Oxaliplatin followed by chemotherapy with Gemcitabine and Tarceva.

Current Secondary Outcome Measures (submitted: February 14, 2012)

• Median overall survival. [ Time Frame: Two years ]
  To determine the overall survival (OS) and the tumor recurrence pattern (local versus distant).
• Rate of resections with engative margins and complete pathological response. [ Time Frame: Two years ]
  To determine the rate of negative margin resections and complete pathological response (cPR).
• Response rate to neoadjuvant treatment of tumor markers (CEA, CA19-9) [ Time Frame: Two years ]
  To determine the reponse rate to the neoadjuvant treatment of speficic tumor markers (CEA, Ca19-9).
• Ratio of objective responses (RECIST). [ Time Frame: Two years ]
  To determine the ratio of objective responses according to RECIST criteria.
• Prognosis accuracy of serum protein profiles [ Time Frame: Two years ]
  To determine the prognosis accuracy of serum protein profiles in these subjects.
• Viability of the collection of pre-treatment tumor samples [ Time Frame: Two years ]
  To determine the feasibility of the collection of pre-treatment (baseline) tumor samples and to set pathological correlations with the response after neoadyuvant treatment.
• Adverse events [ Time Frame: Two years ]
  To determine the safety, toxicity and feasibility of this therapeutical regimen as neoadyuvant treatment.

Original Secondary Outcome Measures (submitted: February 10, 2012)

• Secondary outcome measure [ Time Frame: Two years ]
  Median overall survival.
• Secondary outcome measure [ Time Frame: Two years ]
  Percentage of negative margin resections and complete pathological response.
• Secondary outcome measure [ Time Frame: Two years ]
  Response rate to neoadjuvant treatment tumor markers.
• Secondary outcome measure [ Time Frame: Two years ]
  Proportion of objective responses (RECIST).
• Secondary outcome measure [ Time Frame: Two years ]
  Assessment of prognosis accuracy in serum protein profiles.
• Secondary outcome measure [ Time Frame: Two years ]
  Assessment of the viability of the collection of pre-treatment tumor samples and to establish pathological correlations with response after treatment.
• Secondary outcome measure [ Time Frame: Two years ]
  Adverse events.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Neoadjuvant Treatment in Patients With Pancreatic Cancer That is Potentially Resectable
• Official Title: Phase II Study of Neoadjuvant Treatment With Gemcitabine, Tarceva and Oxaliplatin Followed by Chemotherapy With Tarceva and Gemcitabine in Patients With Pancreas Adenocarcinoma With Borderline Resectability.
• Brief Summary: Phase II study of neoadjuvant treatment with Gemcitabine, Tarceva and Oxaliplatin followed by chemotherapy with Tarceva and Gemcitabine in patients with pancreatic adenocarcinoma with borderline resectability. The primary objective is to determine the resectability rate of patients with pancreas adenocarcinoma with borderline resectability determined radiologically, treated with Gemcitabine, Tarceva and Oxaliplatin followed by radiotherapy with Gemcitabine and Tarceva.

Detailed Description

Patients with borderline resectable pancreatic adenocarcinoma are more likely to develop perioperative complications due to the complexity of surgery. In these patients there is also an increased risk of systemic relapse due to the advanced stage of the tumor as well as a higher possibility of having positive margins. Therefore, the treatment of these patients need to be decided based on a multidisciplinary strategy. Besides of that the use of systemic neoadjuvant chemotherapy as induction therapy, followed by sequential chemoradiotherapy is a very attractive therapeutic modality.

The neoadjuvant treatment offers the potential advantages of reducing the tumor stage, increasing resectability and decreasing postoperative complications.

The administration of chemotherapy and radiotherapy before surgery represent an strategy for early treatment of micrometastatic disease, present in most of these patients, and to identify patients with rapid progression of the disease.

For all the reasons above, the investigators consider it's of great interest to design new studies that combine systemic neoadjuvant chemotherapy followed by chemoradiotherapy with neoadjuvant intention in patients with pancreas cancer locally advanced.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pancreatic Cancer

Intervention

• Drug: Gemcitabine
  1000mg/m2 / / 40mg/m2
  Other Name: gemzar
• Radiation: Radiotherapy
  50.4 Gy
• Drug: Tarceva
  100mg/day
  Other Name: Erlotinib
• Drug: Oxaliplatin
  100mg/m2 (only in QT)
  Other Name: ELOXATIN

Study Arms

Experimental: QT + QRT

Chemotherapy (6 cycles x 14 days): Gemcitabine 1000 mg/m2 (day 1) + Oxaliplatin 100 mg/m2 (day 2) + Tarceva 100 mg/day.

Chemoradiotherapy (5,5 weeks): Gemcitabine 40 mg/m2 (2 days/week) + Tarceva 100 mg/day + Radiotherapy (1,8 Gy/day x 28 doses, total dose: 50,4 Gy).

Interventions:

• Drug: Gemcitabine
• Radiation: Radiotherapy
• Drug: Tarceva
• Drug: Oxaliplatin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 20, 2012): 6
• Original Estimated Enrollment (submitted: February 10, 2012): 25
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Before the beginning of the specific protocol procedures must be obtained and documented a written consent form. Patients must have sufficient capacity to understand and sign the consent form.
• Exocrine pancreatic potentially resectable carcinoma, histologically confirmed.
• Aged 18-75 years.
• OMS functional state (FE) from 0-2 and Karnofsky functional state 70%.
• Radiologically or measurable disease, defined as borderline resectability disease.
• Appropriate biological parameters: neutrophils > 1.500/mL; platelets > 100.000/mL; hemoglobin > 10 g/dl.Serum creatinine < 1,5 x upper limit of normal (LSN); alkaline phosphatase < 3 x LSN and bilirubin < 1,5 x LSN; AST and ALT 2,5 x LSN.
• Controlled biliary obstruction in all the patients before their inclusion in the study.
• Absence of peripheral neuropathy grade 2.
• Life expectancy of at least 3 months.

Exclusion Criteria:

• Previous administration of chemotherapy, radiotherapy or any investigational agents for pancreatic cancer treatment.
• Administration of other experimental treatment during this study or in the previous 6 months.
• Pregnancy, inappropriate or unsafe use of contraceptive methods or women who are breast-feeding.
• Clinically significant heart disease(for example: congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not properly controlled with medication or myocardial infarction in the last 12 months).
• Presence of significant ophthalmologic anomaly, included: severe dry eye syndrome, Sjogren syndrome, dry keratoconjunctivitis, severe exposure keratopathy, conditions that might increase the risk of epithelium complications.
• Patients with lack of physical integrity of the upper gastrointestinal tract or bad absorption syndromes or unable to ingest the tablets.
• Other previous bad or concurrent diseases, with the exception of nonmelanoma skin cancer.
• Medical or psychiatric pathologies that are severe or uncontrolled.
• Distant metastases.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT01531712
• Other Study ID Numbers: ICO-20431; 2010-021872-27 ( EudraCT Number ); GEMERLOXA ( Other Identifier: ICO )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Institut Català d'Oncologia
• Study Sponsor: Institut Català d'Oncologia
• Collaborators: Not Provided

Investigators

• Principal Investigator: Berta Laquente, MD; ICO

• PRS Account: Institut Català d'Oncologia
• Verification Date: August 2017