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
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
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Phase