Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery

Conditions

• Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Gemcitabine — DRUG
  See arm for details.
• Oxaliplatin — DRUG
  See arm for details.
• Dexamethasone — DRUG
  See arm for details.
• Floxuridine (FUDR) — DRUG
  See arm for details.
• Implanted Medical Device — DEVICE
  Implanted hepatic arterial infusion pump by surgical oncology, to deliver HAI therapy

Study Details

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.

Key Dates

Start date

May 7, 2021

Status verified

Apr 2026

Primary completion

May 31, 2027

Completion

May 31, 2027

Study Design

Enrollment

164 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

assess progression-free survival (PFS) [ Time Frame: 2 years ]

Central Contacts

• Andrea Cercek, MD
  646-888-4189
  [email protected]
• William Jarnagin, MD
  212-639-7601

Locations (10)

Find similar trials in Bethesda, MD

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