Nab-paclitaxel in Combination With Gemcitabine in Fragile Patients With Advanced Pancreatic Cancer

NCT02382263 | Completed Phase 1

• 1 other identifier: PHR-2012-01
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 15

Brief Summary

In the list of cancer mortality by type of cancer pancreatic cancer ranks 4th in USA and the 6th in Europe. The estimated figures for 2010 in the USA were 42,000 new cases and 36,000 deaths from pancreatic cancer. The survival rate at 5 years after diagnosis is 4.6% in the USA. In Europe the figures are similar, with survival at 1, 3 and 5 years of 16%, 6% and 4%, respectively. Most patients are diagnosed in advanced stages that are no longer operable, so that treatment goals are often the prolongation of survival and palliation of symptoms. The aim of the study is to explore whether the new combination nab-paclitaxel plus gemcitabine is a therapeutic advance for this fragile population for which it is assumed that some modifications in dose and schedule of administration may be necessary in patients with good performance status. It is ultimately to find out the clinical benefit of this combination, but first making sure that dose and schedule of the combination are tolerable for these fragile patients. For this, the investigators have chosen a design that includes two stages: the first step aimed at choosing the safest treatment regimen for these patients among a group of treatment regimens used in other clinical trials. The second step will evaluate the effectiveness of the two regimens with the better results in the previous step.

Conditions

Advanced Pancreatic Cancer

Keywords

Advanced pancreatic cancer; Fragile; Nab-paclitaxel

Outcome Measures

Primary Outcomes (2)

• PHASE I: To select the schemes with the best therapeutic indexes of the combination of gemcitabine and nab-paclitaxel in fragile patients with advanced pancreatic cancer.

  Phase I: Therapeutic index. Criteria: Early mortality all causes at 30 and 60 days, Adverse Events grade 3 and 4, treatment discontinuation due to toxicity and relative dose intensity

  Up to 2 months

• PHASE II: Evaluate the effectiveness of two selected schemes of gemcitabine and nab-paclitaxel, vs. gemcitabine alone. (Six months overall survival)

  Six months overall survival

  Up to 6 months

Secondary Outcomes (6)

• Phase I: evaluate safety profile of gemcitabine and nab-paclitaxel schemes. (Number of events per patient according to NCI-CTC-AE criteria)

  Up to 6 months

• Phase I: evaluate objective response rate. (Response rate will be evaluated according RECIST criteria)

  Up to 6 months

• Phase II: progression free survival (Time from randomization to disease progression according RECIST criteria)

  Up to 8 months

• Phase II: objective response rate (Response rate will be evaluated according RECIST criteria)

  Up to 6 months

• Phase II: to explore changes induced by treatment on tumor Marker CA19.9

  Up to 8 months

Study Arms (4)

Arm B

EXPERIMENTAL

Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4

Drug: Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4

Arm C

EXPERIMENTAL

Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4

Drug: Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4

Arm D

EXPERIMENTAL

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4

Drug: Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4

Arm E

EXPERIMENTAL

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4

Drug: Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4

Interventions

Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4 DRUG

Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 days 1 \& 15 in a 28 days cycle

Arm B

Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4 DRUG

Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 days 1,8 \& 15 in a 28 days cycle

Arm C

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4 DRUG

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 days 1 \& 15 in a 28 days cycle

Arm D

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4 DRUG

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 days 1,8 \& 15 in a 28 days cycle

Arm E

Eligibility Criteria

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

You may qualify if:

• Patients who are 18 years or older;
• Patients with histological or, if not possible, cytologic confirmed adenocarcinoma of the pancreas.
• Patients with metastatic pancreatic cancer;
• Patient with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 2
• Adequate hematopoietic, hepatic and renal function:
• Neutrophil count \>= 1.5 x 10\*9/L;
• Platelet count \>= 100 x 10\*9/L;
• Bilirubin \<= 1.5 x ULN;
• AST and/or ALT \<= 2.5 x ULN;
• Serum creatinine \<= 1.5 x ULN.
• Investigators must ensure that patients enrolled in the study will be available for all study procedures, including tumor biopsy, chemotherapy treatment, and follow up.
• Investigators must ensure that patients have the ability to understand the requirements of the study and provide signed informed consent.
• Women of childbearing potential and men who wish to participate in the study must agree to use adequate contraception since the signing of informed consent until at least 3 months after stopping the study medication;
• Signed Informed Consent.

You may not qualify if:

• Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with patient eligibility for treatment;
• History of any psychiatric condition that might impair patient?s ability to understand or to comply with the requirements of the study or to provide informed consent;
• Concurrent anticancer therapy;
• Pregnant or breast-feeding women (documented methods of birth control are required in those with reproductive potential);
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs;
• History of life threatening reaction to gemcitabine or abraxane;
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) \<=1.
• Previous treatment with chemotherapy or chemoradiotherapy for advanced pancreatic cancer.

Sponsors & Collaborators

• PH Research, S.L.: lead

Study Sites (15)

Complexo Hospitalario Universitario A Coruña

A Coruña, A Coruña, 15006, Spain

Location

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, A Cosuña, 15706, Spain

Location

Hospital Universitari Vall D'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Donostia

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

Complejo Hospitalario Regional Virgen de Las Nieves

Granada, Granada, 18014, Spain

Location

Complejo Hospitalario Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Hospital Ramón Y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario Madrid Sanchinarro

Madrid, Madrid, 28050, Spain

Location

Complejo Hospitalario Regional de Málaga

Málaga, Málaga, 29010, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitari I Politècnic La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel; Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Manuel Hidalgo, MD

  Hospital Universitario Madrid Sanchinarro

  STUDY CHAIR

• Fernando Rivera, MD

  HOSPITAL UNIVERSITARIO MARQUÉS DE VELDECILLA

  PRINCIPAL INVESTIGATOR

• Teresa Macarulla, MD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

• Carmen Guillén, MD

  Hospital Universitario Ramon y Cajal

  PRINCIPAL INVESTIGATOR

• Rafael López, MD

  COMPLEXO HOSPITALARIO UNIVERSITARIO DE SANTIAGO

  PRINCIPAL INVESTIGATOR

• Roberto Pazo, MD

  Hospital Miguel Servet

  PRINCIPAL INVESTIGATOR

• Manuel Valladares, MD

  COMPLEXO HOSPITALARIO UNIVERSITARIO A CORUÑA

  PRINCIPAL INVESTIGATOR

• Roberto P Díaz, MD

  Hospital Universitario La Fe

  PRINCIPAL INVESTIGATOR

• Inmaculada Alés, MD

  COMPLEJO HOSPITALARIO REGIONAL DE MÁLAGA

  PRINCIPAL INVESTIGATOR

• Joaquina Martínez, MD

  COMPLEJO HOSPITALARIO REGIONAL VIRGEN DE LAS NIEVES

  PRINCIPAL INVESTIGATOR

• Adelaida La Casta, MD

  Hospital Donostia

  PRINCIPAL INVESTIGATOR

• Rut Vera, MD

  Complejo Hospitalario de Navarra

  PRINCIPAL INVESTIGATOR

• Andrés Muñoz, MD

  COMPLEJO HOSPITALARIO GREGORIO MARAÑÓN

  PRINCIPAL INVESTIGATOR

• José I Martín, MD

  HOSPITAL UNIVERSITARIO FUNDACIÓN JIMÉNEZ DIAZ

  PRINCIPAL INVESTIGATOR

• Javier Sastre, MD

  Hospital San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 6, 2015
• Study Start: April 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

ES (15)