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CompletedNCT03807999Updated Jan 17, 2019

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

A Phase 2 interventional study of Nab-paclitaxel and Gemcitabine in Pancreatic Neoplasm, sponsored by Hacettepe University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-17.

Sponsored by Hacettepe University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 10 months after the study started (first participant enrolled Feb 2015, registered Jan 2019).
Phase
Phase 2
Study type
Interventional
Enrollment
125
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

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

Arm 1:

Nab-paclitaxel 125 mg/m2 as 30- to 40-minute infusion (maximum infusion time not to exceed 40 minutes) once weekly for 3 weeks followed by a week of rest. plus Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) once weekly for 3 weeks followed by a week of rest.

OR

Arm 2:

Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) administered weekly for 7 weeks followed by a week of rest (8-week cycle; cycle 1 only), followed by cycles of weekly administration for 3 weeks (on days 1, 8, and 15) followed by one week of rest (4-week cycle).

All patients will be considered for available second-line therapies or best supportive care on the discretion of the investigators.

02

Conditions studied

  • Pancreatic Neoplasm
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 125 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
  1. Patients with active infection. 16. Patients with chronic diarrhea.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
125 participants (actual)

Study arms

  • Active comparator
    Nab-paclitaxel + Gemcitabine

    Nab-paclitaxel 125 mg/m2 as 30- to 40-minute infusion (maximum infusion time not to exceed 40 minutes) once weekly for 3 weeks followed by a week of rest. plus Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) once weekly for 3 weeks followed by a week of rest.

    Drug: Nab-paclitaxel · Drug: Gemcitabine

  • Experimental
    Gemcitabine

    Gemcitabine 1000 mg/m2 as a 30- to 40-minute infusion (maximum 40 minutes) administered weekly for 7 weeks followed by a week of rest (8-week cycle; cycle 1 only), followed by cycles of weekly administration for 3 weeks (on days 1, 8, and 15) followed by one week of rest (4-week cycle).

    Drug: Gemcitabine

Interventions

  • DrugNab-paclitaxel
  • DrugGemcitabine
06

What researchers measure

Primary outcomes

  1. 3-months deterioration-free rate

    EORTC QLQ-C30 (validated version for Turkish using a reduction of at least 10 points as a meaningful clinical difference) will be used to calculate "time until definitive deterioration" (TUDD) and compare patients receiving first-line Nab-Paclitaxel plus Gemcitabine versus first-line gemcitabine for metastatic or locally advanced unresectable adenocarcinoma of the pancreas. EORTC QLQ-C30 scores will be calculated every four weeks following the EORTC QLQ-C30 recommendations for calculations and scoring (EORTC QLQ- C30 published manual).

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

Secondary outcomes

  1. Overall Survival

    Time frame: From first dose to death or end of the therapy, 24 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Yalcin S, Dane F, Oksuzoglu B, Ozdemir NY, Isikdogan A, Ozkan M, Demirag GG, Coskun HS, Karabulut B, Evrensel T, Ustaoglu MA, Ozdemir F, Turna H, Yavuzsen T, Aykan F, Sevinc A, Akbulut H, Yuce D, Hayran M, Kilickap S. Quality of life study of patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma treated with gemcitabine+nab-paclitaxel versus gemcitabine alone: AX-PANC-SY001, a randomized phase-2 study. BMC Cancer. 2020 Mar 30;20(1):259. doi: 10.1186/s12885-020-06758-9. PubMed 32228512 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 7, 2014

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03807999
Lead sponsor
Hacettepe University
Collaborators
Celgene
Responsible party
Suayib Yalcin (Prof. Suayib Yalcin, Hacettepe University) — Principal investigator
First posted
Jan 17, 2019
Start date
Feb 19, 2015
Primary completion
Apr 1, 2018
Completion
Nov 1, 2018
Last update
Jan 17, 2019

Study contacts

Suayib Yalcin
principal investigator · Hacettepe University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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