Chemotherapy +/− FUDR/Dexamethasone Pump for Bile Duct Cancer
Recruiting in Palo Alto (17 mi)
+11 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Must not be taking: FUDR
Disqualifiers: Distant metastasis, Sclerosing cholangitis, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the drug combination used in the trial for bile duct cancer?
Research shows that the combination of gemcitabine, oxaliplatin, and 5-fluorouracil (5-FU) is active in treating bile duct cancer, with studies indicating these drugs work well together and have manageable side effects. Additionally, gemcitabine has been effective in controlling cancer relapse after surgery in bile duct cancer patients.
12345Is the chemotherapy treatment with Gemcitabine, Oxaliplatin, and 5-FU safe for humans?
Research shows that Gemcitabine, Oxaliplatin, and 5-FU have been used safely in treating bile duct and gallbladder cancers, with studies focusing on their safety and effectiveness. These drugs have non-overlapping toxicity, meaning they don't usually cause the same side effects, which can make them safer to use together.
12678How is the chemotherapy treatment with Gemcitabine and Oxaliplatin unique for bile duct cancer?
This treatment combines Gemcitabine and Oxaliplatin, which are drugs that work together to fight bile duct cancer with different mechanisms and have non-overlapping side effects. It is notable for being administered in an outpatient setting, requiring only three visits per month, making it more convenient for patients.
123910Eligibility Criteria
This trial is for adults with a specific type of liver cancer called intrahepatic cholangiocarcinoma that can't be removed by surgery. Participants should have measurable disease, no prior treatments with FUDR or radiation to the liver, and must not have other cancers within the last 3 years. They need to be in good physical condition (ECOG 0-1) and able to undergo general anesthesia.Inclusion Criteria
Platelet count ≥ 75,000/mcL
WBC ≥ 2,000/mcL , ANC ≥ 1000/mcL
Creatinine ≤ 1.8 mg/dL
+10 more
Exclusion Criteria
I have had cancer before, but it was early stage and treated with surgery or radiation within the last 3 years.
I have not had an infection in the week before my planned procedure.
Pregnant or lactating women.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Surgical HAI Pump Placement
Surgical placement of HAI pump for patients in Arm 1
2 weeks
1 visit (in-person)
Treatment
Chemotherapy with GemOx alone or with HAI FUDR/Dex for patients with unresectable cholangiocarcinoma
28-day cycles, ongoing
2 visits per cycle (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 years
Participant Groups
The study compares standard chemotherapy (Gemcitabine and Oxaliplatin) alone versus combined with an implanted pump delivering Floxuridine and Dexamethasone directly into the liver. The goal is to see if adding the pump improves time without disease progression by at least three months compared to chemotherapy alone.
2Treatment groups
Experimental Treatment
Active Control
Group I: HAI FUDR plus GemOx (Arm 1)Experimental Treatment5 Interventions
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.
Group II: GemOx alone (Arm 2)Active Control2 Interventions
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.
Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Gemzar for:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
🇺🇸 Approved in United States as Gemzar for:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
🇨🇦 Approved in Canada as Gemzar for:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
🇯🇵 Approved in Japan as Gemzar for:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memorial Sloan Kettering Cancer CenterNew York, NY
Memorial Sloan Kettering Commack - Limited Protocol ActivitiesCommack, NY
Memorial Sloan Kettering Bergen - Limited Protocol ActivitiesMontvale, NJ
Duke University (Data Collection Only)Durham, NC
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
References
Gemcitabine, oxaliplatin and 5-FU in advanced bile duct and gallbladder carcinoma: two parallel, multicentre phase-II trials. [2022]Gemcitabine, oxaliplatin and 5-fluorouracil (5-FU) are active in biliary tract cancer and have a potentially synergistic mode of action and non-overlapping toxicity. The objective of these trials was to determine response, survival and toxicity separately in patients with bile duct cancer (BDC) and gallbladder cancer (GBC) treated with gemcitabine/oxaliplatin/5-FU chemotherapy.
Phase I study of biweekly oxaliplatin, gemcitabine and capecitabine in patients with advanced upper gastrointestinal malignancies. [2022]Oxaliplatin, gemcitabine and capecitabine are all active agents against upper gastrointestinal and pancreaticobiliary cancers.
Phase II trial of combination chemotherapy with gemcitabine, 5-fluorouracil and cisplatin for advanced cancers of the bile duct, gallbladder, and ampulla of Vater. [2022]For advanced cancers of the bile duct, gallbladder and ampulla of Vater, there are only a few treatment options. We explored the efficacy of the combination of gemcitabine, 5-fluorouracil and cisplatin for advanced biliary cancers.
[Experience of gemcitabine therapy after non-curative resection for biliary tract cancer]. [2022]We report a patient in which gemcitabine therapy was effective for controlling relapse of cancer after noncurative resection for bile duct cancer. A 75-year-old man suffering from bile duct cancer underwent resection of extrahepatic bile duct on December 3, 2002, but surgical margins were positive at the hepatic site and the pancreatic site. Two months after surgery, he began to undergo gemcitabine therapy (1,000 mg/body, biweekly) as adjuvant chemotherapy in the outpatient clinic. The chemotherapy has been continued up to the present. No severe side effect has been observed throughout the treatment. The patient remains well with no evidence of relapse of the cancer 26 months after surgery. Gemcitabine therapy is considered effective as adjuvant chemotherapy for bile duct cancer.
Treatment of Patients with Advanced Biliary Tract Cancer with Either Oxaliplatin, Gemcitabine, and Capecitabine or Cisplatin and Gemcitabine-A Randomized Phase II Trial. [2020]This study is an investigator-initiated randomized phase II trial focusing on the treatment of advanced biliary tract cancer with either oxaliplatin 50 mg/m2 and gemcitabine 1000 mg/m2 on day 1 in a two-week cycle with capecitabine 650 mg/m2 twice-daily continuously or cisplatin 25 mg/m2 and gemcitabine 1000 mg/m2 on day 1 and day 8 in a three-week cycle. One-hundred patients were included. Forty-seven patients received oxaliplatin, gemcitabine, and capecitabine with a median progression-free survival (mPFS) of 5.7 months (95% CI 3.0-7.8) and a median overall survival (mOS) of 8.7 months (95% CI 6.5-11.2). Forty-nine patients received cisplatin and gemcitabine with a mPFS of 7.3 months (95% CI 6.0-8.7) and a mOS of 12.0 months (95% CI 8.3-16.7). This trial confirms a mOS of 12 months with cisplatin and gemcitabine, as found in earlier trials. With a superior tumor control rate of 79% vs. 60% (p = 0.045), a difference in the mPFS of 1.6 months (HR = 0.721, p = 0.1), and a difference in the mOS of 3.3 months (HR = 0.731, p = 0.1), cisplatin and gemcitabine should still be considered the standard first-line treatment for advanced biliary tract cancer.
Weekly gemcitabine for the treatment of biliary tract and gallbladder cancer. [2022]To evaluate the efficacy and safety of weekly administration of gemcitabine treatment in chemotherapy-naïve patients with advanced biliary tract and gallbladder cancer.
Real-World Evidence on Palliative Gemcitabine and Oxaliplatin (GemOx) Combination Chemotherapy in Advanced Biliary Tract Cancer. [2021]Gemcitabine and oxaliplatin (GemOx) is a standard combination regimen in advanced biliary tract cancer (BTC). There is limited evidence on its efficacy and safety in real life.
Efficacy and safety of gemcitabine-based chemotherapies in biliary tract cancer: a meta-analysis. [2022]To investigate the efficacy and safety of gemcitabine (Gem)-based combination chemotherapies for the treatment of advanced biliary tract cancer.
Outpatient chemotherapy with gemcitabine and oxaliplatin in patients with biliary tract cancer. [2022]This phase II study was conducted to determine the efficacy and toxicity of a gemcitabine (GEM) and oxaliplatin (OX) chemotherapy protocol in patients with unresectable biliary tract cancer (BTC). Patients were treated with GEM 1000 mg m-2 (30 min infusion) on days 1, 8, 15, and OX 100 mg m-2 (2 h infusion) on days 1 and 15 (gemcitabine and oxaliplatin (GEMOX-3 protocol), repeated every 28 days. The data were collected according to the Simon 2-stage design for a single centre phase II study (alpha=0.05; beta=0.2). Primary end point was response rate; secondary end points were time-to-progression (TTP), median survival, and safety profile. Thirty-one patients were enrolled in the study between July 2002 and April 2005. Therapeutic responses were as follows: partial response in eight patients (26%, 95% confidence interval (CI) 14-44), stable disease in 14 patients (45%, 95%CI 29-62), resulting in a disease control rate of 71%. Nine patients (29%, 95%CI 16-47) had progressive disease. Median TTP was 6.5 months. Median overall survival was 11 months. Common Toxicity Criteria (CTC) Grade 3-4 toxicities were transient thrombocytopenia (23%), peripheral sensory neuropathy (19%), leucopenia (16%), and anaemia (10%). In conclusion the GEMOX-3 protocol is active and well tolerated in patients with advanced BTC. It can be applied in an outpatient setting with three visits per month only.
Phase II study of mFOLFOX3 (5-fluorouracil, leucovorin, oxaliplatin) as second-line treatment after gemcitabine failure in patients with unresectable/metastatic biliary tract cancer. [2022]We conducted a phase II trial of 5-fluorouracil and oxaliplatin combination chemotherapy as a second-line treatment in unresectable/metastatic biliary tract cancer patients who had failed gemcitabine-based chemotherapy.