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Clinical Trial 19989

Cancer Type: Gastrointestinal Tumor
Study Type: Treatment
NCT#: NCT03257033

Phase: Phase III
Principal Investigator: Parikh, Nainesh

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine plus Nab-Paclitaxel following Induction with sequential IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy for Locally Advanced Pancreatic Cancer

Summary

The study is a multi-center, open-label, randomized active-controlled study of patients with locally advanced pancreatic adenocarcinoma which is unresectable according to NCCN guidelines

Objective

Primary Objective: To compare the Overall Survival, from time of randomization until death, between patients receiving intra-arterial delivery of gemcitabine using the RenovoCath device for 16 weeks vs. continuation of IV gemcitabine and nab-paclitaxel for 16 weeks in those patients with stable disease following induction therapy with IV gemcitabine and nab-paclitaxel and radiation treatment for locally advanced pancreatic adenocarcinoma. Secondary Objectives: To compare in patients with locally advanced, unresectable pancreatic cancer treated with intra-arterial delivery of gemcitabine using the RenovoCath¿ device for 16 weeks vs. continuation of IV gemcitabine and nab-paclitaxel for 16 weeks: 1. Primary Endpoint for treatment received and unresected analysis populations 2. Progression free survival assessed according to RECIST 1.1 for all analysis populations 3. Objective response rate and duration of response 4. Health Related Quality of Life assessed with the EORTC, PCQL-10 and S-PGI questionnaires 5. Degree of peripheral neuropathy 6. Frequency of neutropenia requiring the use of filgrastim or other medications for white blood cell stimulation 7. Tolerability and safety of the combination

Treatments

Therapies

Chemotherapy (NOS); Radiotherapy

Medications

Gemzar (gemcitabine); Nab-paclitaxel (Abraxane); Xeloda (capecitabine); capecitabine (); gemcitabine ()

Inclusion Criteria

Histologically confirmed pancreatic adenocarcinoma with initial diagnosis within 6 weeks of consent

Locally advanced, unresectable disease, as defined by NCCN criteria

ECOG performance status 0-1

Age ≥ 18 years

Lab values as indicated per protocol

Life expectancy > 12 weeks

Women of childbearing potential must have a negative serum or urine pregnancy test within 1 day prior to administration of the first dose of chemotherapy. Women of childbearing potential should only use highly effective methods of contraception during treatment and for up to 6 months following treatment cessation.

Provide written informed consent

Participants willing to participate in the study for at least 8 months

Exclusion Criteria

Any prior treatment for pancreatic cancer OR more than one cycle of gemcitabine and nab-paclitaxel treatment. For subjects who have started on first cycle of gemcitabine and nab-paclitaxel treatment prior to consent, Inclusion Criterion #1 only applies in that the first gemcitabine and nab-paclitaxel dose must be within 6 weeks of confirmed diagnosis.

Any evidence of metastatic disease or another active malignancy within the past two years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.

Participants unable or unwilling to have their first randomized treatment within three weeks of the post induction imaging and within 3 weeks of their last induction treatment

Participants without baseline tumor imaging

Arterial anatomy suitable for IA delivery of gemcitabine to the intended tumor site, determined by CT or MRI, as determined and approved by the sponsor, which precludes the following: (a) Stenosis or occlusion in intended artery for treatment (b) Tortuosity preventing the delivery of the guide sheath and or RenovoCath® catheter to the intended site (c) Inability to exclude major side branches in the area of the intended RenovoCath® occlusion (d) No suitable artery with a diameter greater than 3mm in proximity of at least one side of the tumor (e) Moderate to severe mesenteric vein thrombosis if superior mesenteric artery is only viable treatment artery

Participants with known HIV or active viral hepatitis

Severe infections within 4 weeks prior to the first study treatment, including but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia

Signs or symptoms of infection within 2 weeks prior to the first study treatment

Received oral or IV antibiotics for an infection within 2 weeks prior to the first study treatment. Participants receiving prophylactic antibiotics are eligible

History of severe allergic, anaphylactic, or other hypersensitivity reactions to gemcitabine or nab-paclitaxel

Any anti-cancer therapy including chemotherapy, hormonal therapy, or radiotherapy within 2 weeks prior to initiation of study treatment; or herbal therapy intended as anti-cancer therapy within 1 week prior to initiation of study treatment

Participants with uncontrolled seizures

Cardiovascular disease including unstable angina; therapy for life-threatening cardiac arrhythmia, myocardial infarction, stroke; or New York Heart Association (NYHA) Class III or IV congestive heart failure within the last 3 months prior to initiation of study treatment

Life-threatening visceral disease or other severe concurrent disease, or comorbidities which make it difficult to participate in this study.

Any of the following procedures prior to initiation of study treatment: (a) Catheterization, endoscopy, stent or drain placement within 48 hours Note: Diagnostic laproscopy without surgical intervention and/or port placement do not require any wait time prior to study treatment (b) Minor surgery requiring light sedation within 2 weeks (c) major surgery within 4 weeks

Women who are breastfeeding

Male or female participants of reproductive potential who do not agree to employ two highly effective and acceptable forms of contraception throughout their participation in the study and for 90 days after the last study treatment

Participants concurrently receiving any other investigational agents within 2 weeks prior to the first study treatment

Any psychiatric illness or social situations that would limit compliance with study requirements

Participants unwilling to have standard catherization procedure

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