Nab-paclitaxel and Gemcitabine, in Elderly Patients Untreated Metastatic Pancreatic Adenocarcinoma

NCT02391662 | Completed Phase 2

• 2 other identifiers: BIBABRAX2014-003596-27
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 21

Brief Summary

Cancer incidence is increasing with age and the likelihood of elderly suffering from cancer is 1:3. Although many clinical trials include elderly patients, no results for this subgroup of patients are available. Since there is no specific recommendations for treatment of elderly patients with pancreatic cancer, treatment with gemcitabine alone is the treatment of choice for these patients. Single-agent gemcitabine is the current standard of care, but the addition of cytotoxic and targeted agents to gemcitabine has almost invariably provided no significant survival improvement. Results obtained recently in the MPACT phase III clinical trial in patients with pancreatic cancer treated with nab-paclitaxel combined with gemcitabine have shown improvement in overall survival, but due to in this clinical trial was included patients between 27 and 88 years, it is considered necessary to conduct a specific study for patients over 70 years. The aim of this study is to investigate whether the clinical benefit of nab-paclitaxel associated with gemcitabine can be extended to elderly patients with pancreatic cancer.

Conditions

Pancreatic Carcinoma Metastatic

Keywords

Metastatic Pancreatic Adenocarcinoma; Elderly; Nab-paclitaxel; Gemcitabine

Outcome Measures

Primary Outcomes (1)

• Efficacy of treatment through 3-months deterioration free rate

  The general deterioration of the patient is assessed with the EORTC-QLQ-C30 scale. t will be considered definitive deterioration a decrease of at least 10 points from baseline. We will evaluate the rate of patients free of definitive deterioration at 3 months.

  Up to 3 months

Secondary Outcomes (5)

• Evaluate safety profile of gemcitabine and nab-paclitaxel, measured by Number of events per patient according to NCI-CTC-AE criteria

  Up to 6 months

• Time to tumor progression

  Up to 8 months

• Overall survival

  Up to 12 months

• Objective radiographic response (ORR)

  Up to 6 months

• CA 19.9 biomarker response

  Up to 6 months

Study Arms (1)

Nab-paclitaxel plus Gemcitabine

EXPERIMENTAL

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

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

Interventions

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

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

Also known as: Nab-paclitaxel

Nab-paclitaxel plus Gemcitabine

Gemcitabine 1000 weeks 1,2,3/4 DRUG

Gemcitabine 1000 days 1,8 \& 15 in a 28 days cycle

Also known as: Gemcitabine

Nab-paclitaxel plus Gemcitabine

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Histologically or cytologically-confirmed pancreatic adenocarcinoma
• Stage IV disease (metastatic only)
• No prior systemic therapy for their diagnosis (except in adjuvant setting \> six months previously)
• ECOG performance status of 0-1
• Age \>=70 years.
• Evidence of either or both of the following:
• RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter \>= 20mm using conventional techniques or \>= 10 mm with spiral CT scan)
• An elevated serum CA19-9 at baseline ( \>= 2X ULN)
• Female patients must be either surgically sterile or postmenopausal.
• Male patients must be surgically sterile or must agree to use a condom during sex with women who may become pregnant while receiving the study drug and for 6 months after receiving the last dose.
• Adequate bone marrow function:
• ANC \>= 1500/uL
• platelet count \>= 100,000/uL
• hemoglobin \>= 9.0 g/dL
• Adequate hepatic function:

You may not qualify if:

• Any prior systemic or investigational therapy for metastatic pancreatic cancer.
• Inability to comply with study and/or follow-up procedures.
• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
• Presence of central nervous system or brain metastases.
• Life expectancy \< 12 weeks.
• Pregnancy (positive pregnancy test) or lactation.
• Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years.
• Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
• Known, existing uncontrolled coagulopathy.
• Pre-existing sensory neuropathy \> grade 1.
• Major surgery within 4 weeks of the start of study treatment, without complete recovery.
• Concurrent/pre-existing use of anticoagulant treatment.

Sponsors & Collaborators

• Asociación de Oncología Médica del Hospital de Cruces: lead
• Apices Soluciones S.L.: collaborator
• Celgene: collaborator

Study Sites (21)

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

Location

Centre Hospitalari de Manresa

Manresa, Barcelona, 08240, Spain

Location

Hospital Universitario de Cruces

Barakaldo, Gipuzkoa, 48903, Spain

Location

Hospital Clinico Universitario Virgen de La Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital Xeral de Vigo

Vigo, Pontevedra, 36204, Spain

Location

Complejo Hospitalario Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, 38320, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Infanta Cristina

Badajoz, 06080, Spain

Location

Hospital Universitario Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

Ico Girona

Girona, 17007, Spain

Location

Complejo Hospitalario de Jaén

Jaén, 23007, Spain

Location

C. Hospitalario Universitario Insularmaterno-Infantil

Las Palmas de Gran Canaria, 35016, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Hm Sanchinarro

Madrid, 28050, Spain

Location

Hospital Quirón Madrid

Madrid, 28223, Spain

Location

Complexo Hospitalario Universitario de Ourense

Ourense, 32005, Spain

Location

Complejo Hospitalario Regional Virgen Macarena

Seville, 41009, Spain

Location

Hospital Virgen Del Rocio

Seville, 41013, 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

• Guillermo López Vivanco, MD

  Hospital de Cruces

  STUDY CHAIR

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: March 12, 2015
• First Posted: March 18, 2015
• Study Start: June 23, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

ES (21)