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Trial record 1 of 1 for:    swog | Resectable Pancreatic Adenocarcinoma | durham, North Carolina, U.S.
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S1505: Combination Chemotherapy or Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02562716
Recruitment Status : Completed
First Posted : September 29, 2015
Results First Posted : July 23, 2021
Last Update Posted : October 19, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
SWOG Cancer Research Network

Study Description
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Brief Summary:
This randomized phase II trial studies how well fluorouracil, irinotecan hydrochloride, and oxaliplatin (combination chemotherapy) works and compares to gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating patients with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, oxaliplatin, gemcitabine hydrochloride, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective than gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Resectable Pancreatic Carcinoma Drug: Fluorouracil Drug: Gemcitabine Hydrochloride Drug: Irinotecan Hydrochloride Drug: Oxaliplatin Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation Procedure: Pancreatectomy Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Perioperative mFOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma
Actual Study Start Date : January 6, 2016
Actual Primary Completion Date : May 31, 2020
Actual Study Completion Date : September 26, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (mFOLFIRINOX, surgery)
Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.
 Drug: Fluorouracil
Given IV
Other Names:
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fluracil
  • 5-FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluracil
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757

Drug: Irinotecan Hydrochloride
Given IV
Other Names:
  • Campto
  • Camptosar
  • Camptothecin 11
  • Camptothecin-11
  • CPT 11
  • CPT-11
  • Irinomedac
  • U-101440E

Drug: Oxaliplatin
Given IV
Other Names:
  • 1-OHP
  • Ai Heng
  • Aiheng
  • Dacotin
  • Dacplat
  • Diaminocyclohexane Oxalatoplatinum
  • Eloxatin
  • Eloxatine
  • JM-83
  • Oxalatoplatin
  • Oxalatoplatinum
  • RP 54780
  • RP-54780
  • SR-96669

Procedure: Pancreatectomy
Undergo pancreatectomy
Other Names:
  • Excision of the Pancreas
  • Pancreas Excision
Experimental: Arm II (gemcitabine, nab-paclitaxel, and surgery)
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
 Drug: Gemcitabine Hydrochloride
Given IV
Other Names:
  • dFdCyd
  • Difluorodeoxycytidine Hydrochloride
  • Gemzar
  • LY-188011

Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Given IV
Other Names:
  • ABI 007
  • ABI-007
  • Abraxane
  • Albumin-bound Paclitaxel
  • Albumin-Stabilized Nanoparticle Paclitaxel
  • nab-paclitaxel
  • Nanoparticle Albumin-bound Paclitaxel
  • Nanoparticle Paclitaxel
  • protein-bound paclitaxel

Procedure: Pancreatectomy
Undergo pancreatectomy
Other Names:
  • Excision of the Pancreas
  • Pancreas Excision


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 4 years for the estimates of median overall survival. Up to 2 years for Statistical Analysis 1 and 2, comparing the observed 2-year overall survival (OS) to the null hypothesis of 40%, in each arm. ]
    OS is the length of time between protocol registration and patient death


Secondary Outcome Measures :
  1. Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [ Time Frame: Duration of treatment and follow up until death or 4 years post registration. ]
    Only adverse events that are possibly, probably or definitely related to preoperative and postoperative chemotherapy are reported.

  2. Number of Patients Going to Surgery for Resection After Preoperative Chemotherapy. [ Time Frame: Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy). ]
  3. Number of Patients Achieving R0 Resection After Preoperative Chemotherapy. [ Time Frame: Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy). ]
    R0 resection classification is defined as macroscopically complete tumor removal with negative microscopic surgical margins (bile duct, pancreatic parenchyma, and superior mesenteric artery margins).

  4. Number of Participants With a Response Following Preoperative Chemotherapy, Including Confirmed and Unconfirmed, Complete and Partial Response, Per RECIST 1.1. [ Time Frame: Up to 6 months post registration (and within 2 to 4 weeks after the last dose of Cycle 3 preoperative chemotherapy.). ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  5. Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection. [ Time Frame: Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy). ]

    Pathologic response was evaluated after the patient had surgery, and was based on local pathology review of the resected surgical specimen, according to the following Tumor Regression Grade definitions:

    0: Complete response - no residual tumor

    1. Moderate response - minimal residual cancer (single cells or small groups of cancer cells)
    2. Minimal response - residual cancer outgrown by fibrosis
    3. Poor or no response - no definite response identified (minimal or no tumor kill; extensive residual cancer)

  6. Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection. [ Time Frame: Up to 4 years ]

    Loco-regional recurrence is defined as any evidence of new disease within the pancreatic tumor bed based on surveillance scans. The pancreatic tumor bed includes:

    1. Superior mesenteric artery and vein lymph nodes
    2. Lymph nodes in porta hepatis (bile duct, portal vein, hepatic artery lymph nodes)
    3. Lymph nodes around left renal vein, inferior vena cava or aorta
    4. Celiac axis lymph nodes.

    Distant Recurrence is defined as any evidence of new disease outside the primary tumor bed (liver, lungs, etc.) based on surveillance scans.


  7. Disease-free Survival From the Time of R0 or R1 Resection. [ Time Frame: Up to 4 years ]
    Disease-free survival (DFS) is calculated for patients who undergo surgical resection (R0/R1). DFS will be measured from the date of surgical resection to date of first documentation of recurrence (loco-regional or distant) or death due to any cause. Patients last known to be alive and free of disease will be censored at date of last contact.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically proven pancreatic adenocarcinoma; histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible
  • Patients must have measurable disease in the pancreas; computed tomography (CT) scans or magnetic resonance imaging (MRIs) used to assess measurable disease must have been completed within 28 days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form

  • Patients must have resectable primary tumor based on contrast-enhanced CT or MRI (CT or MRI without contrast as part of positron emission tomography [PET]/CT or PET/MRI is NOT acceptable; CT or MRI with contrast as part of PET/CT or PET/MRI is acceptable) of the chest, abdomen, and pelvis, where resectable is defined as:

    • No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (and, if present, replaced right hepatic artery)
    • No involvement, or < 180° interface between tumor and vessel wall, of the portal vein and/or superior mesenteric vein; and patent portal vein/splenic vein confluence
    • No evidence of metastatic disease
    • Note: for tumors of the body and tail of the pancreas, involvement of the splenic artery and vein of any degree is considered resectable disease
  • CT scans or MRIs used to assess disease at baseline must be submitted for central review
  • Patients must have surgical consult to verify patient is a surgical candidate within 21 days prior to registration
  • Patients must not have received prior surgery, radiation therapy, chemotherapy, targeted therapy, or any investigational therapy for pancreatic cancer
  • Patients must have a Zubrod performance status of 0-1
  • Absolute neutrophil count (ANC) >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Hemoglobin >= 9 g/dL
  • Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN
  • Serum albumin >= 3 g/dL
  • Serum creatinine =< IULN within 14 days prior to registration
  • Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements will NOT be eligible
  • No prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer, in situ breast (ductal or lobular) cancer, or other cancer for which the patient has been disease and treatment-free for two years
  • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method for up to 3 months after the final administered dose of chemotherapy; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures, he/she is responsible for beginning contraceptive measures
  • Sites must seek additional patient consent for the future use of specimens
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562716


Locations
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Sponsors and Collaborators
SWOG Cancer Research Network
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Davendra Sohal SWOG Cancer Research Network
  Study Documents (Full-Text)

Documents provided by SWOG Cancer Research Network:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] September 4, 2020

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

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Responsible Party: SWOG Cancer Research Network
ClinicalTrials.gov Identifier: NCT02562716    
Other Study ID Numbers: S1505
NCI-2015-01236 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S1505 ( Other Identifier: SWOG )
S1505 ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
First Posted: September 29, 2015    Key Record Dates
Results First Posted: July 23, 2021
Last Update Posted: October 19, 2022
Last Verified: October 2022
Additional relevant MeSH terms:
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Adenocarcinoma
Pancreatic Neoplasms
Pancreatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Paclitaxel
Camptothecin
Albumin-Bound Paclitaxel
 Gemcitabine
Fluorouracil
Oxaliplatin
Irinotecan
Pancrelipase
Pancreatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents