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 Plus 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 37(13):1062-1069

PMid: PMID30817250 | PMC number: PMC6494359

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

Other Clinical Trials

SWOG Clinical Trial Number
S1922

Randomized Phase II Study of Ramucirumab and Paclitaxel versus FOLFIRI in Refractory Small Bowel Adenocarcinoma

Research Committee(s)
Gastrointestinal Cancer
Activated
12/16/2019
Accrual
0%
Open
Phase
II
SWOG Clinical Trial Number
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SWOG Clinical Trial Number
S1613