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

This study has been terminated.
(Due to a low recruitment rate since start of recruitment period.)
Sponsor:
Information provided by (Responsible Party):
Institut Català d'Oncologia
ClinicalTrials.gov Identifier:
NCT01531712
First received: January 11, 2012
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: Gemcitabine
Radiation: Radiotherapy
Drug: Tarceva
Drug: Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Institut Català d'Oncologia:

Primary Outcome Measures:
  • Resectability rate after neoadjuvant treatment with chemotherapy plus chemoradiotherapy. [ Time Frame: Two years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Median overall survival. [ Time Frame: Two years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To determine the ratio of objective responses according to RECIST criteria.

  • Prognosis accuracy of serum protein profiles [ Time Frame: Two years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    To determine the safety, toxicity and feasibility of this therapeutical regimen as neoadyuvant treatment.


Enrollment: 6
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531712

Locations
Spain
Institut Català d'Oncologia
L'Hospitalet, Barcelona, Spain, 08907
Sponsors and Collaborators
Institut Català d'Oncologia
Investigators
Principal Investigator: Berta Laquente, MD ICO
  More Information

No publications provided

Responsible Party: Institut Català d'Oncologia
ClinicalTrials.gov Identifier: NCT01531712     History of Changes
Other Study ID Numbers: ICO-20431, 2010-021872-27, GEMERLOXA
Study First Received: January 11, 2012
Last Updated: July 20, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Institut Català d'Oncologia:
neoadjuvant treatment
borderline resectability

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Erlotinib
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014