SWOG clinical trial number
S1313

A Phase Ib/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) versus Modified FOLFIRINOX Alone in Patients with Good Performance Status Metastatic Pancreatic Adenocarcinoma

Closed
Phase
I-II
Accrual
73%
Abbreviated Title
Ph Ib/II Rando mFOLFIRINOX+PEGPH20 vs mFOLFIRINOX Alone in Good PS Met Pancreatic Adenocarcinoma
Status Notes
This study is permanently closed effective 07/01/2017.
Activated
01/06/2014
Participants
Limited: Institutions Listed on the Title Page

Research committees

Gastrointestinal Cancer

Treatment

5-Fluorouracil Irinotecan Leucovorin Calcium Oxaliplatin PEGPH20

Eligibility Criteria Expand/Collapse

Newly diagnosed, untreated metastatic histologically or cytologically documented pancreatic adenocarcinoma with no known history of brain metastases; Measurable metastatic disease; No prior treatment with oxaliplatin or irinotecan within 3 years prior to registration. No prior chemotherapy in metastatic setting. No Prior abdominal radiation therapy; Zubrod PS 0-1; must be >/= 18 and </= 75 years of age; ANC >/= 1,500/uL; Platelets >/= 100,000/uL; Hemoglobin >/= 9 g/dL; Total bilirubin </= IULN; AST </= 2.5 x IULN; ALT </= 2.5 X IULN; or AST & ALT both </= 5.0 IULN in with liver metastasis; Serum albumin >/= 3 g/dL; Serum creatinine </= ULN or calculated creatinine clearance > 50 ml/min; INR </= 1.2; must not be receiving warfarin for therapeutic use, history of cerebrovascular accidnet, history of TIA requiring intervention or treatment, pre-existing carotid artery disease requiring intervention or treatment, or current use of megestrol acetate; Not receiving chronic treatment with systemic steroids or other immuno-suppressive agent; Not have liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis; Not have active bleeding or a pathological condition that is associated with a high risk of bleeding; Must be on active treatment for HIV; No non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment; No other prior malignancy is allowed except for: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which patient is is complete remission, or any other cancer from which the patient has been disease free for five years; Must not be pregnant or nursing; Tumor (paraffin block or slides) available for submission and willing to submit blood samples

Publication Information Expand/Collapse

2019

A Phase IB/II Randomized Study of FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase versus FOLFIRINOX alone in Patients with Metastatic Pancreatic Adenocarcinoma (SWOG S1313)

R Ramanathan;S McDonough;P Philip;S Hingorani;Jill Lacy;J Kortmansky;J Thumar;E Chiorean;AF Shields;D Behl;P Mehan;R Gaur;T Seery;K Guthrie;H Hochster Journal of Clinical Oncology Feb 28:JCO1801295. doi: 10.1200/JCO.18.01295. [Epub ahead of print]

PMid: PMID30817250

2018

A phase Ib/II randomized study of mfolfirinox (mffox) + pegylated recombinant human hyaluronidase (pegph20) versus mffox alone in patients with good performance status metastatic pancreatic adenocarcinoma (mPC): SWOG S1313 (NCT #01959139)

R Ramanathan;S McDonough;PA Philip;S Hingorani;J Kortmansky;J Thumar;EG Chiorean;AF Shields;D Behl;P Mehan;R Gaur;T Seery;K Guthrie;H Hochster Journal of Clinical Oncology 36(suppl 4S; abstr 208); ASCO Gastrointestinal Cancers Symposium 2018 (January 18-20, 2018, San Francisco, CA), poster session

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Research Committee(s)
Gastrointestinal Cancer
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Activated
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Open
Phase
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