A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR/Dexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma

Who is this study for? Patients with Intrahepatic Cholangiocarcinoma
What treatments are being studied? Gemcitabine+Oxaliplatin
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study will compare the safety and effects of HAI floxuridine and dexamethasone combined with the standard chemotherapy drugs gemcitabine and oxaliplatin (GemOx) with those of GemOx alone in people with untreated cholangiocarcinoma that cannot be removed with surgery. The researchers want to find out whether the study treatment works better than the standard chemotherapy to delay progression of disease. For the study treatment to be considered better than the standard treatment, the study treatment should increase the time until progression of disease by an average of 3 months, compared with the usual approach.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years

• ECOG 0-1

• Histologically confirmed intrahepatic cholangiocarcinoma (also variously reported as peripheral cholangiocarcinoma, cholangiolar carcinoma or cholangiocellular carcinoma) (IHC). Confirmation of the diagnosis at MSKCC or at the enrolling institution must be obtained prior to randomization.

• Clinical or radiographic evidence of metastatic disease confined to the liver. Note: presence of regional (porta hepatis) lymph node metastases will be allowed, provided they are amenable to resection. (Note: If peritoneal or other extrahepatic disease is found at time of pump placement, the pump will not be implanted. The patient will be removed from study, deemed nonevaluable and will not count toward the overall study accrual.)

• Radiographically measurable disease. Measurable disease is defined as disease that can be assessed with 2-dimensional measurements on a cross-sectional imaging. Minimum lesion size is 2 cm in greatest diameter as per RECIST criteria.

• Disease must be considered unresectable at the time of preoperative evaluation.\*

• Considered candidate for general anesthesia, abdominal exploration and hepatic artery pump placement.

• Patients with chronic hepatitis and/or cirrhosis are eligible, but must be Child-Pugh class A.

• WBC ≥ 2,000/mcL , ANC ≥ 1000/mcL

• Platelet count ≥ 75,000/mcL

• Creatinine ≤ 1.8 mg/dL

• Total bilirubin \< 1.5 mg/dL

• Hgb \> 7 g/dL The % involvement of the liver will be determined by radiologists after review of imaging

Locations
United States
Maryland
National Heart, Lung, and Blood Institute (NIH) (Data Collection Only)
RECRUITING
Bethesda
Missouri
Washington University (Data Collection Only)
RECRUITING
St Louis
North Carolina
Duke University (Data Collection Only)
RECRUITING
Durham
New Jersey
Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth - Limited Protocol Activities
RECRUITING
Middletown
Memorial Sloan Kettering Bergen - Limited Protocol Activities
RECRUITING
Montvale
New York
Memorial Sloan Kettering Commack - Limited Protocol Activities
RECRUITING
Commack
Memorial Sloan Kettering Westchester - Limited Protocol Activities
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Nassau - Limited Protocol Activities
RECRUITING
Uniondale
Other Locations
Netherlands
Erasmus University (Data Collection Only)
RECRUITING
Rotterdam
Contact Information
Primary
Andrea Cercek, MD
cerceka@mskcc.org
646-888-4189
Backup
William Jarnagin, MD
212-639-7601
Time Frame
Start Date: 2021-05-07
Estimated Completion Date: 2026-05
Participants
Target number of participants: 164
Treatments
Experimental: HAI FUDR plus GemOx (Arm 1)
Surgical HAI pump placement. 2. HAI FUDR \[(0.12 mg/kg/day) x wt (kg) x (30ml) / pump flow rate \] and dexamethasone \[1 mg/day \* 30\] / pump flow rate \] on Day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. 3. Gemcitabine (800 mg/m2 IV over 30 minutes) and oxaliplatin (85 mg/ m2 IV over 120 minutes on Days 1 and 15 of each cycle; however, for patients in Arm 1, initiation of systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first dose of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter.
Active_comparator: GemOx alone (Arm 2)
Gemcitabine (800 mg/m2 IV over 30 minutes) and oxaliplatin (85 mg/m2 IV over approximately 120 minutes) on Days 1 and 15 of each 28-day cycle.For patients in Arm 2, systemic therapy will be administered on Days 1 and Day 15 of each Cycle on a 28-day cycle basis, compromised of Gemcitabine and Oxaliplatin. If a patient randomized to Arm 2 has intrahepatic progression on any follow-up scan during study treatment, that patient will be eligible to crossover to Arm 1 and commence to pump placement surgery and HAI FUDR treatment. Patients with any extrahepatic progression will not be eligible to utilize the crossover arm. Arm 2 patients will have 28 days from date of the scan showing intrahepatic progression to proceed to the crossover arm.
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov

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