CompletedPhase 2

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

125 participantsStarted 2015-02-19

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:

Exclusion criteria

✕. 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.

What they're measuring

3-months deterioration-free rate

Timeframe: From first dose of therapy to third month of therapy, 3 months

Trial details

NCT IDNCT03807999

SponsorHacettepe University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-04-01

View on ClinicalTrials.gov More Pancreatic Neoplasm trials