Clinical trial NCT02391662: Nab-paclitaxel and Gemcitabine, in Elderly Patients Untreated Metastatic Pancreatic Adenocarcinoma
Official title: A Phase II Study of Nab-paclitaxel and Gemcitabine, in Elderly Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Carcinoma Metastatic
Keywords: Metastatic Pancreatic Adenocarcinoma
Elderly
Nab-paclitaxel
Gemcitabine
Lead sponsor: Asociación de Oncología Médica del Hospital de Cruces
Sponsor class: OTHER
Collaborators: name: Apices Soluciones S.L.
name: Celgene
First posted: 2015-03-18
Enrollment: 80
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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:

  * Total bilirubin \<= 1.5 X ULN
  * AST (SGOT) \<= 2.5 X ULN
  * ALT (SGPT) \<= 2.5 X ULN
* Adequate renal function as determined by either:

  * Serum creatinine \<= 1.5 X ULN
  * Calculated or measured creatinine clearance \>= 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used).
* Ability to understand the nature of this study protocol and give written informed consent
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Efficacy of treatment through 3-months deterioration free rate
timeFrame: Up to 3 months
Secondary outcomes:
measure: Evaluate safety profile of gemcitabine and nab-paclitaxel, measured by Number of events per patient according to NCI-CTC-AE criteria
timeFrame: Up to 6 months
measure: Time to tumor progression
timeFrame: Up to 8 months
measure: Overall survival
timeFrame: Up to 12 months
measure: Objective radiographic response (ORR)
timeFrame: Up to 6 months
measure: CA 19.9 biomarker response
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Granollers
country: Spain
facility: Hospital General de Granollers
state: Barcelona
city: Manresa
country: Spain
facility: Centre Hospitalari de Manresa
state: Barcelona
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces
state: Gipuzkoa
city: El Palmar
country: Spain
facility: Hospital Clinico Universitario Virgen de La Arrixaca
state: Murcia
city: Vigo
country: Spain
facility: Hospital Xeral de Vigo
state: Pontevedra
city: San Cristóbal de La Laguna
country: Spain
facility: Complejo Hospitalario Universitario de Canarias
state: Tenerife
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D'Hebron
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Girona
country: Spain
facility: Ico Girona
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: Las Palmas de Gran Canaria
country: Spain
facility: C. Hospitalario Universitario Insularmaterno-Infantil
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Hm Sanchinarro
city: Madrid
country: Spain
facility: Hospital Quirón Madrid
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
city: Sevilla
country: Spain
facility: Complejo Hospitalario Regional Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Virgen Del Rocio
Study officials:
affiliation: Hospital de Cruces
name: Guillermo López Vivanco, MD
role: STUDY_CHAIR
References: