Clinical trial NCT03807999: Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine For The First Line Treatment of Pancreas Cancer
Official title: Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine For The First Line Treatment of Metastatic or Locally Advanced Unresectable Adenocarcinoma of The Pancreas: A Phase II Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Neoplasm
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Celgene
First posted: 2019-01-17
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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:

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.

15. Patients with active infection. 16. Patients with chronic diarrhea.

Primary outcomes:
measure: 3-months deterioration-free rate
timeFrame: From first dose of therapy to third month of therapy, 3 months
Secondary outcomes:
measure: Overall Survival
timeFrame: From first dose to death or end of the therapy, 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe University
name: Suayib Yalcin
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.