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

NCT01531712 | Terminated Phase 2

• 3 other identifiers: ICO-204312010-021872-27GEMERLOXA
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

neoadjuvant treatment; borderline resectability

Outcome Measures

Primary Outcomes (1)

• Resectability rate after neoadjuvant treatment with chemotherapy plus chemoradiotherapy.

  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.

  Two years

Secondary Outcomes (7)

• Median overall survival.

  Two years

• Rate of resections with engative margins and complete pathological response.

  Two years

• Response rate to neoadjuvant treatment of tumor markers (CEA, CA19-9)

  Two years

• Ratio of objective responses (RECIST).

  Two years

• Prognosis accuracy of serum protein profiles

  Two years

Study Arms (1)

QT + QRT

EXPERIMENTAL

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; Radiation: Radiotherapy; Drug: Tarceva; Drug: Oxaliplatin

Interventions

Gemcitabine DRUG

1000mg/m2 / / 40mg/m2

Also known as: gemzar

QT + QRT

Radiotherapy RADIATION

50.4 Gy

QT + QRT

Tarceva DRUG

100mg/day

Also known as: Erlotinib

QT + QRT

Oxaliplatin DRUG

100mg/m2 (only in QT)

Also known as: ELOXATIN

QT + QRT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Absence of peripheral neuropathy grade 2.
• Life expectancy of at least 3 months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Català d'Oncologia: lead

Study Sites (1)

Institut Català d'Oncologia

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Radiotherapy; Erlotinib Hydrochloride; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Therapeutics; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Berta Laquente, MD

  ICO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: February 13, 2012
• Study Start: February 10, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

ES (1)