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S1505: Combination Chemothera...

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

Last Updated: 2022-10-19

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-06

Study Completion Date

2022-09-26

Brief Summary

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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.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To assess 2-year overall survival in each treatment arm (fluorouracil, irinotecan hydrochloride, and oxaliplatin \[modified (m)FOLFIRINOX\] and gemcitabine \[gemcitabine hydrochloride\]/nab-paclitaxel \[paclitaxel albumin-stabilized nanoparticle formulation\]) in patients with resectable pancreatic cancer.

II. If the stated threshold is met in one or both arms: to choose the better regimen with respect to 2-year overall survival.

SECONDARY OBJECTIVES:

I. To estimate, for all patients and within treatment arms: frequency and severity of adverse events associated with chemotherapy in the perioperative setting.

II. To estimate, for all patients and within treatment arms: proportion of patients going to surgery for resection after preoperative chemotherapy.

III. To estimate, for all patients and within treatment arms: proportion of patients achieving macroscopically complete tumor removal with negative microscopic surgical margins (R0) resection after preoperative chemotherapy.

IV. To estimate, for all patients and within treatment arms: overall response rate following preoperative chemotherapy, including confirmed and unconfirmed, complete and partial response, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

V. To estimate, for all patients and within treatment arms: pathologic response rates after R0 or macroscopically complete tumor removal with any positive microscopic surgical margin (R1) resection.

VI. To estimate, for all patients and within treatment arms: patterns of recurrence (loco-regional, distant) after R0 or R1 resection.

VII. To estimate, for all patients and within treatment arms: disease-free survival from the time of R0 or R1 resection.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oxaliplatin intravenously (IV) over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 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.

ARM II: 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.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 2 years.

Conditions

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Pancreatic Adenocarcinoma Resectable Pancreatic Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Davendra Sohal

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

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United States

References

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Sohal DPS, Boutin RD, Lenchik L, Kim J, Beg MS, Wang-Gillam A, Wade JL 3rd, Guthrie KA, Chiorean EG, Ahmad SA, Lowy AM, Philip PA, Chang VT. Body composition measurements and clinical outcomes in patients with resectable pancreatic adenocarcinoma - analysis from SWOG S1505. J Gastrointest Surg. 2024 Mar;28(3):232-235. doi: 10.1016/j.gassur.2023.12.022. Epub 2024 Jan 19.

Reference Type DERIVED

PMID: 38445914 (View on PubMed)

Sohal DPS, Duong M, Ahmad SA, Gandhi NS, Beg MS, Wang-Gillam A, Wade JL 3rd, Chiorean EG, Guthrie KA, Lowy AM, Philip PA, Hochster HS. Efficacy of Perioperative Chemotherapy for Resectable Pancreatic Adenocarcinoma: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021 Mar 1;7(3):421-427. doi: 10.1001/jamaoncol.2020.7328.

Reference Type DERIVED

PMID: 33475684 (View on PubMed)

Ahmad SA, Duong M, Sohal DPS, Gandhi NS, Beg MS, Wang-Gillam A, Wade JL 3rd, Chiorean EG, Guthrie KA, Lowy AM, Philip PA, Hochster HS. Surgical Outcome Results From SWOG S1505: A Randomized Clinical Trial of mFOLFIRINOX Versus Gemcitabine/Nab-paclitaxel for Perioperative Treatment of Resectable Pancreatic Ductal Adenocarcinoma. Ann Surg. 2020 Sep 1;272(3):481-486. doi: 10.1097/SLA.0000000000004155.

Reference Type DERIVED

PMID: 32740235 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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NCI-2015-01236

Identifier Type: REGISTRY

Identifier Source: secondary_id

S1505

Identifier Type: OTHER

Identifier Source: secondary_id

S1505

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180888

Identifier Type: NIH

Identifier Source: secondary_id

View Link

S1505

Identifier Type: -

Identifier Source: org_study_id

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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

Study Results

Basic Information

Brief Summary

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Chemotherapy and Radiation Therapy Before Surgery Followed by Gemcitabine in Treating Patients with Pancreatic Cancer

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Detailed Description

Conditions

Study Design

Study Groups

Arm I (mFOLFIRINOX, surgery)

Fluorouracil

Irinotecan Hydrochloride

Oxaliplatin

Pancreatectomy

Arm II (gemcitabine, nab-paclitaxel, and surgery)

Gemcitabine Hydrochloride

Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Pancreatectomy

Interventions

Fluorouracil

Gemcitabine Hydrochloride

Irinotecan Hydrochloride

Oxaliplatin

Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Pancreatectomy

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Sponsors

National Cancer Institute (NCI)

SWOG Cancer Research Network

Responsible Party

Principal Investigators

Davendra Sohal

Locations

University of Alabama at Birmingham Cancer Center

University of South Alabama Mitchell Cancer Institute

Anchorage Associates in Radiation Medicine

Anchorage Radiation Therapy Center

Alaska Breast Care and Surgery LLC

Alaska Oncology and Hematology LLC

Alaska Regional Hospital

Alaska Women's Cancer Care

Anchorage Oncology Centre

Katmai Oncology Group

Providence Alaska Medical Center

University of Arizona Cancer Center at Saint Joseph's

University of Arizona Cancer Center-Orange Grove Campus

Banner University Medical Center - Tucson

University of Arizona Cancer Center-North Campus

CHI Saint Vincent Cancer Center Hot Springs

Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Kaiser Permanente-Anaheim

Kaiser Permanente-Deer Valley Medical Center

Sutter Auburn Faith Hospital

Sutter Cancer Centers Radiation Oncology Services-Auburn

Kaiser Permanente-Baldwin Park

Kaiser Permanente-Bellflower

Alta Bates Summit Medical Center-Herrick Campus

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Mills-Peninsula Medical Center

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Eden Hospital Medical Center

Sutter Davis Hospital

Epic Care-Dublin

Bay Area Breast Surgeons Inc

Epic Care Partners in Cancer Care

Kaiser Permanente-Fontana

Kaiser Permanente-Fremont

Palo Alto Medical Foundation-Fremont

Kaiser Permanente-Fresno

Kaiser Permanente - Harbor City

Kaiser Permanente-Irvine

UC San Diego Moores Cancer Center

Kaiser Permanente Los Angeles Medical Center