Overview

Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine For The First Line Treatment of Pancreas Cancer

Status:
Completed
Trial end date:
2018-11-01
Target enrollment:
0
Participant gender:
All
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 pancreatic cancer. Arm 1: Nab-paclitaxel plus gemcitabine Arm 2: Gemcitabine alone
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hacettepe University
Collaborator:
Celgene
Treatments:
Albumin-Bound Paclitaxel
Gemcitabine
Paclitaxel
Pancrelipase
Criteria
Inclusion Criteria:

1. Written informed consent.

2. Histologically or cytologically confirmed treatment-naïve metastatic or locally
advanced adenocarcinoma of the pancreas not amenable to curative radiotherapy or
surgery.

3. 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).

4. Age ≥ 18 years.

5. ECOG Performance Status 0 or 1.

6. Adequate bone marrow function: granulocyte count ≥1500 and platelet count ≥100,000 per
cubic millimeter.

7. 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 Criteria:

1. 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.

2. Inability to comply with study and/or follow-up procedures.

3. 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.

4. 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.

5. Presence of central nervous system or brain metastases.

6. Life expectancy <12 weeks.

7. Pregnancy (positive pregnancy test) or lactation.

8. 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.

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. 14. Patients older than 76 years of age.

15. Patients with active infection. 16. Patients with chronic diarrhea.