Status:
COMPLETED
Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine For The First Line Treatment of Pancreas Cancer
Lead Sponsor:
Hacettepe University
Collaborating Sponsors:
Celgene
Conditions:
Pancreatic Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized, multicenter, phase II study of with nab-paclitaxel plus gemcitabine or gemcitabine alone for the treatment of chemotherapy-naïve patients with locally advanced or metastatic panc...
Detailed Description
This is a randomized, multicenter, phase II study of with nab-paclitaxel plus gemcitabine or gemcitabine alone for the treatment of chemotherapy-naïve patients with locally advanced or metastatic panc...
Eligibility Criteria
Inclusion
- Written informed consent.
- Histologically or cytologically confirmed treatment-naïve metastatic or locally advanced adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery.
- Measurable disease as defined by RECIST (ie, target lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral computed tomography \[CT\] scan).
- Age ≥ 18 years.
- ECOG Performance Status 0 or 1.
- Adequate bone marrow function: granulocyte count ≥1500 and platelet count ≥100,000 per cubic millimeter.
- Adequate liver function as defined by the following criteria:
- Total serum bilirubin \<2 mg/dl.
- ALP/GGT \<5 x ULN.
- Transaminases ALT/AST ≤ 2.5 x ULN.
Exclusion
- Any prior systemic or investigational therapy for metastatic pancreatic cancer. Systemic therapy administered alone or in combination with radiation in the adjuvant setting is permitted if it is completed \> 6 months prior to the time of study enrollment.
- Inability to comply with study and/or follow-up procedures.
- Presence of significant comorbidity including 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 and any other major organ failure.
- Presence of any 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.
- 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 coumadin. 14. Patients older than 76 years of age.
- 15\. Patients with active infection. 16. Patients with chronic diarrhea.
Key Trial Info
Start Date :
February 19 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT03807999
Start Date
February 19 2015
End Date
November 1 2018
Last Update
January 17 2019
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