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Study of Individualized Selection of Chemotherapy in Patients With Advanced Pancreatic Carcinoma According to Therapeutic Targets

Primary Purpose

Advanced Pancreatic Carcinoma

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

gemcitabine, or gemcitabine and capecitabine, or gemcitabine and erlotinib, or FOLFIRINOX, or FOLFOX, or FOLFIRI.

Gemcitabine, Gemcitabine-Capecitabine, Gemcitabine-Erlotinib, FOLFOXIRI, FOLFOX, FOLFIRI

About this trial

This is an interventional treatment trial for Advanced Pancreatic Carcinoma focused on measuring Therapeutic targets in Pancreas

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histological or cytological diagnosis of pancreatic carcinoma.
Patients> 18 years.
Measurable or not measurable disease.
Life expectancy> 3 months at the discretion of the investigator.
Good general condition determined by the ECOG scale (score 0-1)
Candidate for first-line systemic chemotherapy according to standard practice.
Availability of tumor tissue or opportunity for tumor biopsy for the - determination of biomarkers and their correlation with treatment.
Adequate hematologic function: ANC> 1.5 x 103 / L, absolute count of platelets> 100 x 109 / L, normal values of INR and PTT.
Adequate liver function: total serum bilirubin <2 mg / dL, ALT and AST <3 times the upper limit established by the laboratory (LSR) or <5 LSR in patients with liver metastases.
Adequate renal function: serum creatinine <1.5 LSR.

Exclusion Criteria:

Patients who have received prior chemotherapy for advanced pancreatic carcinoma. Will not result excluding patients who had previously received adjuvant treatment with gemcitabine or fluoropyrimidines. Also not will be excluded patients who had previously received preoperative neoadjuvant treatment for localized disease with chemotherapy and / or radiotherapy.
Patients for whom is contraindicated the administration of either drug used in first-line treatment for pancreatic cancer: Gemcitabine, 5'Fluouracilo, Leucovorin, Capecitabine, Oxaliplatin, Irinotecan, Erlotinib.
Pregnant or breastfeeding women

Sites / Locations

Hospital Universitario de Fuenlabrada
Hospital Universitario Madrid Sanchinarro

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A

Arm B

Arm Description

Control treatment arm will be treated with any of the schemes used in the study according to the discretion of the physician responsible

treatment guided by the therapeutic targets

Outcomes

Primary Outcome Measures

Overall survival

The primary endpoint is survival as measured from the start of treatment the patient to the death of the patient according to the Kaplan-Meier. For each treatment arm will determine the overall survival and the survival and actuarial survival at one year

Secondary Outcome Measures

Full Information

NCT ID

NCT01454180

First Posted

October 11, 2011

Last Updated

October 8, 2015

Sponsor

Centro Nacional de Investigaciones Oncologicas CARLOS III

Collaborators

Hospital Universitario de Fuenlabrada, Apices Soluciones S.L., Grupo Hospital de Madrid

1. Study Identification

Unique Protocol Identification Number

NCT01454180

Brief Title

Study of Individualized Selection of Chemotherapy in Patients With Advanced Pancreatic Carcinoma According to Therapeutic Targets

Official Title

Ensayo Fase II de selección Individualizada Del Tratamiento de Quimioterapia en Pacientes Con Carcinoma de páncreas Avanzado en función de la determinación de Dianas terapéuticas en el Tejido Tumoral

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centro Nacional de Investigaciones Oncologicas CARLOS III

Collaborators

Hospital Universitario de Fuenlabrada, Apices Soluciones S.L., Grupo Hospital de Madrid

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine the proportion of patients alive after 12 months of the beginning of the trial in patients with advanced pancreatic carcinoma individually selected and grouped according to the expression in tumor tissue for therapeutic targets.

Detailed Description

Phase II, open two branches, in which conventional treatment is administered to patients diagnosed with metastatic pancreatic carcinoma. Patients will be randomized (1:1) to a treatment arm or control arm of experimental treatment guided by the therapeutic targets. Patients in the control treatment arm will be treated with any of the schemes used in the study according to the discretion of the physician responsible. Patients will be analyzed as "intention to treat." In the experimental treatment arm (therapeutic targets) and within 15 days will determine the markers of therapeutic targets detailed in the protocol, either from pre-existing tumor sample or a fresh sample obtained by biopsy. Based on the results of this analysis, we prescribe a chemotherapy treatment determined for possible treatments currently used in pancreatic carcinoma, gemcitabine, gemcitabine and capecitabine, gemcitabine and erlotinib, FOLFIRINOX, FOLFOX, FOLFIRI. Treatment duration is indefinite .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Pancreatic Carcinoma

Keywords

Therapeutic targets in Pancreas

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Active Comparator

Arm Description

Control treatment arm will be treated with any of the schemes used in the study according to the discretion of the physician responsible

Arm Title

Arm B

Arm Type

Experimental

Arm Description

treatment guided by the therapeutic targets

Intervention Type

Drug

Intervention Name(s)

gemcitabine, or gemcitabine and capecitabine, or gemcitabine and erlotinib, or FOLFIRINOX, or FOLFOX, or FOLFIRI.

Intervention Description

Gemcitabine 1000 mg/m2 weekly for 7 weeks, then weekly regimen of 3 weeks every 4 weeks. Gemcitabine - Capecitabine (GEM-CAP):Gemcitabine 1000 mg/m2 weekly for 3 weeks, Capecitabine 830 mg/m2 orally every 12 hours daily for 3 weeks; every 4 weeks. Gemcitabine-Erlotinib: Gemcitabine 1000 mg/m2 weekly for 7 weeks, then weekly regimen of 3 weeks every 4 weeks, Erlotinib 100 mg orally daily FOLFOXIRI: Oxaliplatin 85 mg/m2,irinotecan 180 mg/m2, folinic acid 400 mg/m2, 5'Fluouracilo 400 mg / m2, 5 'fluorouracil 2400 mg/m2 continuous intravenous infusion of 46 hours. Repeated every 14 days. FOLFOX: Oxaliplatin 85 mg/m2, folinic acid 400 mg/m2, 400 mg/m2 5'Fluouracilo, 2400 mg/m2 5'Fluouracilo continuous intravenous infusion of 46 hours. Repeated every 14 days. FOLFIRI: Irinotecan 180 mg/m2, folinic acid 400 mg/m2, 400 mg/m2 5'Fluouracilo intravenous bolus, 5'Fluouracilo 2400 mg / m2 continuous intravenous infusion for 46 hours. Repeated every 14 days.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine, Gemcitabine-Capecitabine, Gemcitabine-Erlotinib, FOLFOXIRI, FOLFOX, FOLFIRI

Intervention Description

Primary Outcome Measure Information:

Title

Overall survival

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histological or cytological diagnosis of pancreatic carcinoma. Patients> 18 years. Measurable or not measurable disease. Life expectancy> 3 months at the discretion of the investigator. Good general condition determined by the ECOG scale (score 0-1) Candidate for first-line systemic chemotherapy according to standard practice. Availability of tumor tissue or opportunity for tumor biopsy for the - determination of biomarkers and their correlation with treatment. Adequate hematologic function: ANC> 1.5 x 103 / L, absolute count of platelets> 100 x 109 / L, normal values of INR and PTT. Adequate liver function: total serum bilirubin <2 mg / dL, ALT and AST <3 times the upper limit established by the laboratory (LSR) or <5 LSR in patients with liver metastases. Adequate renal function: serum creatinine <1.5 LSR. Exclusion Criteria: Patients who have received prior chemotherapy for advanced pancreatic carcinoma. Will not result excluding patients who had previously received adjuvant treatment with gemcitabine or fluoropyrimidines. Also not will be excluded patients who had previously received preoperative neoadjuvant treatment for localized disease with chemotherapy and / or radiotherapy. Patients for whom is contraindicated the administration of either drug used in first-line treatment for pancreatic cancer: Gemcitabine, 5'Fluouracilo, Leucovorin, Capecitabine, Oxaliplatin, Irinotecan, Erlotinib. Pregnant or breastfeeding women

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manuel Hidalgo, M.D.,PhD

Organizational Affiliation

CNIO

Official's Role

Study Director

Facility Information:

Facility Name

Hospital Universitario de Fuenlabrada

City

Fuenlabrada

State/Province

Madrid

ZIP/Postal Code

28950

Country

Spain

Facility Name

Hospital Universitario Madrid Sanchinarro

City

Madrid

ZIP/Postal Code

28050

Country

Spain

12. IPD Sharing Statement

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Study of Individualized Selection of Chemotherapy in Patients With Advanced Pancreatic Carcinoma According to Therapeutic Targets

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