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

Pancreatic Carcinoma Metastatic Clinical Trial

Official title:

A Phase II Study of Nab-paclitaxel and Gemcitabine, in Elderly Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391662
• Other study ID #: BIBABRAX
• Secondary ID: 2014-003596-27
• Status: Completed
• Phase: Phase 2
• Start date: June 23, 2015
• Est. completion date: March 2019

Study information

• Verified date: August 2019
• Source: Asociación de Oncología Médica del Hospital de Cruces
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Carcinoma Metastatic
• Pancreatic Neoplasms

Intervention

Drug:
• Nab-paclitaxel 125 mg/m2 weeks 1,2,3/4
Nab-paclitaxel 125 mg/m2 days 1,8 & 15 in a 28 days cycle
• Gemcitabine 1000 weeks 1,2,3/4
Gemcitabine 1000 days 1,8 & 15 in a 28 days cycle

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Infanta Cristina	Badajoz
Spain	Hospital Universitario de Cruces	Barakaldo	Gipuzkoa
Spain	Hospital Universitario Vall D'Hebron	Barcelona
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital Clinico Universitario Virgen de La Arrixaca	El Palmar	Murcia
Spain	Ico Girona	Girona
Spain	Hospital General de Granollers	Granollers	Barcelona
Spain	Complejo Hospitalario de Jaén	Jaén
Spain	C. Hospitalario Universitario Insularmaterno-Infantil	Las Palmas de Gran Canaria
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	Hospital Quirón Madrid	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Hm Sanchinarro	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Centre Hospitalari de Manresa	Manresa	Barcelona
Spain	Complexo Hospitalario Universitario de Ourense	Ourense
Spain	Complejo Hospitalario Universitario de Canarias	San Cristóbal de La Laguna	Tenerife
Spain	Complejo Hospitalario Regional Virgen Macarena	Sevilla
Spain	Hospital Virgen Del Rocio	Sevilla
Spain	Hospital Xeral de Vigo	Vigo	Pontevedra

Sponsors (3)

Lead Sponsor	Collaborator
Asociación de Oncología Médica del Hospital de Cruces	Apices Soluciones S.L., Celgene

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate safety profile of gemcitabine and nab-paclitaxel, measured by Number of events per patient according to NCI-CTC-AE criteria	Number of events per patient according to NCI-CTC-AE criteria	Up to 6 months
Secondary	Time to tumor progression	Time from patient inclusion to disease progression according RECIST criteria	Up to 8 months
Secondary	Overall survival	Time from patient inclusion to death	Up to 12 months
Secondary	Objective radiographic response (ORR)	Response rate will be evaluated according RECIST criteria	Up to 6 months
Secondary	CA 19.9 biomarker response	CA 19.9 biomarker response will be considered a decrease of at least 50% compared to baseline	Up to 6 months