Skip to main content
OpenTrials
Completed

NCT Number: NCT02043730

Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.

Pancreatic cancer is the fourth cause of cancer mortality: there are different treatment approaches to locally advanced pancreatic cancer management.

Generally, gemcitabine alone is considered a reasonable approach for advanced pancreatic cancer patients but we need a chemotherapeutic regimen able to prevent as much as possible a progression of the disease. Nab-paclitaxel (Abraxane) recently demonstrated an interesting activity profile in advanced pancreatic cancer. A combination of Nab-paclitaxel and gemcitabine has been demonstrated superior to gemcitabine alone in metastatic patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreatic Cancer Stage II Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

A.O. Universitaria Ospedali Riuniti, Ancona, AN, Italy

Loading trial locations.

About this study

Study population: Locally advanced unresectable pancreatic cancer patients

Elegibility criteria:

  • Written informed consent
  • Age >18 < 75 years
  • Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer
  • At least one lesion measurable with CT or MRI scan
  • Performance Status (ECOG) 0-1 at study entry
  • Life expectancy of at least 3 months
  • Adequate marrow, liver and renal function
  • Effective contraception if the risk of conception exists (in the Informed Consent for the patients the descriptions of possible contraceptives is reported

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • Age >18 < 75 years
  • Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer
  • At least one lesion measurable with CT or MRI scan
  • Performance Status (ECOG) 0-1 at study entry
  • Life expectancy of at least 3 months
  • Adequate marrow, liver and renal function
  • Effective contraception if the risk of conception exists (in the Informed Consent for the patients the descriptions of possible contraceptives is reported)

Exclusion criteria

  • Previous chemotherapy or radiotherapy for pancreatic cancer
  • Severe cardiovascular disease
  • Thrombotic or embolic events
  • Acute or subacute intestinal occlusion or history of inflammatory bowel disease
  • Known hypersensitivity to study drug
  • Known drugs or alcohol abuse
  • Pregnant or breastfeeding women
  • Previous or concurrent malignancy; except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and with evidence of no recurrence for at least 5 years prior to randomization
  • Unable to sign informed consent

Treatment and study plan

Nab-Paclitaxel and Gemcitabine

Drug

Chemotherapy will consist of nab-paclitaxel 125 mg/mq over 30 min and gemcitabine 1000 mg/mq weekly on days 1, 8 and 15 of a 28-day cycle

Other names: abraxane, gemzar

Gemcitabine

Drug

gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.

Other names: gemzar

Primary outcomes

  1. Progression Rate

    Time frame: progression rate is evaluated after 3 cycles of chemotherapy

    Assuming an expected progression rate in the control arm of 40% and an auspicated progression rate in the experimental arm of 20%,with one-tailed alpha=0.05, 80% power, 124 patients are required for the final analysis

Secondary outcomes

  1. Quality of Response

    Time frame: Response to treatment is evaluated according to the RECIST criteria at the end of chemotherapy

    All patients must be considered in response analysis, including those who discontinue treatment or who die for any reason prior to response evaluations

  2. Esplore the effects of nab-paclitaxel in terms of toxicity

    Time frame: every 3 cycles of chemotherapy

    Treatment-emergent adverse events, drug-related adverse events and safety laboratory parameters will be analysed by treatment groups and CTCAE grade

  3. Progression Free Survival

    Time frame: time from the start of the treatment until PD or death

    Progression free survival time will be defined as the time from randomization until the date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented.

    Patients who did not progress will be censored at the last date they were known to be alive.

    Patients who died of disease and for whom a date of progression is not available will be considered to have progressed on the day of their death

  4. Overall Survival

    Time frame: the time from randomization to the date of death

    Overall survival time will be defined as the time from randomization to the date of death. If the subject has not died, survival will be censored on the last date the subject was known to be alive (last date of follow up).

Sponsors and collaborators

Lead sponsor

Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

Other

Collaborators

  • Istituto Nazionale Tumori di Napoli
  • Unità Sperimentazioni cliniche

Registry information

Official study title

A Phase II Randomized Trial Comparing a Combination of Abraxane and Gemcitabine Versus Gemcitabine Alone as First Line Treatment in Locally Advanced Unresectable Pancreatic Cancer. GAP (Gemcitabine Abraxane Pancreas) Trial

Acronym: GAP

Important dates

Study start
2014
Primary completion
2016
Study completion
2019
First posted
Jan 23, 2014
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.