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

Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

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

OBJECTIVES: PHASE I: to determine the recommended phase 2 dose of nab-paclitaxel in
combination with cisplatin, capecitabine, and gemcitabine.

PHASE II: to evaluate the feasibility and the activity of the PAXG regimen in terms of
6-months progression-free survival in patients with stage III and IV pancreatic cancer.

OUTLINE Phase I - dose finding single institution trial, followed by a randomized open label
multicenter phase II trial.

Phase II: Patients will be stratified by stage (III vs IV) and CA19.9 level (< 10 x ULN
versus >10 x ULN); Patients will be randomly assigned to receive PAXG (arm A) or PEXG
regimen (arm B).

Treatment plan (phase II):

Arm A: PAXG every 4 weeks (1 cycle): cisplatin at 30 mg/m2 on days 1 and 15, nab-paclitaxel
at the RP2D on days 1 and 15, capecitabine at 1250 mg/ m2 days 1-28, gemcitabine at 800 mg/
m2 on days 1 and 15.

Arm B: PEXG every 4 weeks (1 cycle): same as above for cisplatin, gemcitabine and
capecitabine, plus epirubicin at 30 mg/m2 on days 1 and 15.

Treatment will be administered for a maximum of 6 cycles or until there is a clinical

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).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

first cycle toxicity

Outcome Description:

Dose Limiting Toxicity definition: DLT will be defined as any of the following events attributable to the administered study drugs: Hematologic toxicity Grade ≥ 4 neutropenia lasting 7 days or more Grade ≥ 3 febrile neutropenia or fever of unknown origin ≥ 38.5°C Grade 4 thrombocytopenia Grade 3 thrombocytopenia which required transfusions Nausea or vomiting Grade ≥ 3 nausea or vomiting despite maximal antiemetic therapy Diarrhea Grade ≥ 3 diarrhea despite optimal management of the event Neurological toxicity Any Grade ≥ 2 neurological toxicity Other non-hematologic toxicity Any grade ≥ 3 toxicities or representing a shift by 2 grades from baseline (in case of abnormal baseline) Failure to recover Failure to recover to grade ≤ 1 toxicity (except alopecia) or to baseline values after delaying the initiation of next cycle by > 2 weeks.

Outcome Time Frame:

after one month from treatment start

Safety Issue:


Principal Investigator

Michele Reni, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



Italy: Ministry of Health

Study ID:




Start Date:

November 2012

Completion Date:

December 2014

Related Keywords:

  • Pancreatic Cancer
  • pancreatic adenocarcinoma
  • stage III disease
  • stage IV disease
  • chemotherapy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms