Study of Nab-paclitaxel and Gemcitabine in Elderly Patients with Pancreatic Cancer

Phase 1

• Conditions: Metastatic pancreatic cancer; MedDRA version: 17.1 Level: PT Classification code 10033610 Term: Pancreatic carcinoma metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003596-27-ES
• Lead Sponsor: Asociación de Oncología Médica del Hospital de Cruces (ASONMEC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-16
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1. Histologically or citologically-confirmed pancreatic adenocarcinoma
2. Stage IV disease (metastatic only)
3. No prior systemic therapy for their diagnosis (except in adjuvant setting > six months previously)
4. ECOG performance status of 0-1
5. Age >=70 years.
6. 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)
7. Female patients must be either surgically sterile or postmenopausal.
8. 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.
9. Adequate bone marrow function:
- ANC >= 1500/uL
- platelet count >= 100,000/uL
- hemoglobin >= 9.0 g/dL
10. Adequate hepatic function:
- Total bilirubin <= 1.5 X ULN
- AST (SGOT) <= 2.5 X ULN
- ALT (SGPT) <= 2.5 X ULN
11. 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).
12. Ability to understand the nature of this study protocol and give written informed consent
13.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

1. Any prior systemic or investigational therapy for metastatic pancreatic cancer.
2. Inability to comply with study and/or follow-up procedures.
3. 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.
4. Presence of central nervous system or brain metastases.
5. Life expectancy < 12 weeks.
6. Pregnancy (positive pregnancy test) or lactation.
7. 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.
8. 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.
9. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
10. Known, existing uncontrolled coagulopathy.
11. Pre-existing sensory neuropathy > grade 1.
12. Major surgery within 4 weeks of the start of study treatment, without complete recovery.
13. Concurrent/pre-existing use of coumadin.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified