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

• ClinicalTrials.gov Identifier: NCT03807999
• Recruitment Status: Completed
• First Posted: January 17, 2019
• Last Update Posted: January 17, 2019
• Sponsor: Hacettepe University
• Collaborator: Celgene
• Information provided by (Responsible Party): Suayib Yalcin, Hacettepe University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Pancreatic Neoplasm	Drug: Nab-paclitaxel; Drug: Gemcitabine	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 19, 2015
• Actual Primary Completion Date: April 1, 2018
• Actual Study Completion Date: November 1, 2018

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 3-months deterioration-free rate [ Time Frame: From first dose of therapy to third month of therapy, 3 months ]
   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).

Secondary Outcome Measures :

1. Overall Survival [ Time Frame: From first dose to death or end of the therapy, 24 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Sponsors and Collaborators

Hacettepe University

Celgene

Investigators

• Principal Investigator: Suayib Yalcin; Hacettepe University

  Study Documents (Full-Text)

Documents provided by Suayib Yalcin, Hacettepe University:

Study Protocol and Statistical Analysis Plan  [PDF] January 7, 2014

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Suayib Yalcin, Prof. Suayib Yalcin, Hacettepe University
• ClinicalTrials.gov Identifier: NCT03807999
• Other Study ID Numbers: AX-PANC-SY001
• First Posted: January 17, 2019
• Last Update Posted: January 17, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gemcitabine; Paclitaxel; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs