Overview

A Phase I-II Study of PAXG in Stage III-IV Pancreatic Adenocarcinoma

Status:
Completed
Trial end date:
2017-08-01
Target enrollment:
0
Participant gender:
All
Summary
Four-drug combo yielded a statistically significant improvement in progression-free survival and overall survival compared to gemcitabine in patients with advanced pancreatic adenocarcinoma. Nab-Paclitaxel showed promising antitumor activity in patients with pancreatic cancer. Given the synergism of taxanes with gemcitabine, fluoropyrimidines and platinating agents the role of nab-Paclitaxel in a 4-drug regimen will be explored. The aim of this trial is to determine the recommended dose of nab-paclitaxel in combination with cisplatin, capecitabine, and gemcitabine, PAXG regimen (Phase I), and to evaluate the feasibility and the activity of the PAXG regimen in patients with stage III and IV pancreatic cancer.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
IRCCS San Raffaele
Treatments:
Albumin-Bound Paclitaxel
Capecitabine
Cisplatin
Gemcitabine
Paclitaxel
Criteria
Inclusion Criteria:

- Pathologic diagnosis of pancreatic adenocarcinoma

- Stage III or IV disease

- Age > 17 < 76 years

- Karnofsky Performance Status > 50

- Measurable disease (only for phase II part)

- Adequate bone marrow (GB > 3500/mm3, neutrophils > 1500/mm3; platelets > 100000/mm3;
hemoglobin > 10 g/dl), liver (total bilirubin < 2 mg/dL; SGOT e SGPT < 3 UNL) and
kidney function (serum creatinin < 1.5 mg/dL;)

- Written informed consent

Exclusion Criteria:

- previous chemotherapy

- concurrent treatment with other experimental drugs

- previous or concurrent malignancies at other sites with the exception of surgically
cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin
and of other neoplasms without evidence of disease at least from 5 years

- symptomatic brain metastases

- history of interstitial lung disease

- presence of serious disease which can compromise safety (cardiac failure, previous
myocardial infarction within the prior 6 months, cardiac arrhythmia, history of
psychiatric disabilities)

- pregnancy and lactating

- History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).