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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04891289
Recruitment Status : Recruiting
First Posted : May 18, 2021
Last Update Posted : September 9, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Intrahepatic Cholangiocarcinoma Drug: Gemcitabine Drug: Oxaliplatin Drug: Dexamethasone Drug: Floxuridine (FUDR) Device: Implanted Medical Device Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a multi-center, prospective randomized controlled phase II study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR/Dexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma
Actual Study Start Date : May 7, 2021
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024


Arm Intervention/treatment
Experimental: HAI FUDR plus GemOx (Arm 1)

Surgical HAI pump placement. 2. HAI FUDR [(0.12 mg/kg/day) x wt (kg) x (20ml) X 0.9) / pump flow rate (1ml/day)] and dexamethasone [1 mg/day * 20] / pump flow rate (1 ml/day) 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.

Drug: Gemcitabine
See arm for details.

Drug: Oxaliplatin
See arm for details.

Drug: Dexamethasone
See arm for details.

Drug: Floxuridine (FUDR)
See arm for details.

Device: Implanted Medical Device
Implanted hepatic arterial infusion pump by surgical oncology, to deliver HAI therapy

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.
Drug: Gemcitabine
See arm for details.

Drug: Oxaliplatin
See arm for details.




Primary Outcome Measures :
  1. assess progression-free survival (PFS) [ Time Frame: 2 years ]
    will be done using RECIST (version 1.1).


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 initiation of protocol therapy.
  • 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

Exclusion Criteria:

  • Presence of distant metastatic disease. Patients will undergo radiographic evaluation to exclude the possibility of distant metastatic disease. For patients who have undergone pre- or post-operative biopsies that definitively diagnose IHC, the diagnostic studies may be modified at the discretion of the MSKCC Principal Investigator. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection.
  • Patients previously treated with systemic chemotherapy for IHC will be non-eligible.
  • Prior treatment with FUDR.
  • Prior external beam radiation therapy to the liver.
  • Prior ablative therapy to the liver.
  • Diagnosis of sclerosing cholangitis.
  • Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis; surgically related ascites does not exclude the patient).
  • Active infection within one week prior to HAI placement.
  • Pregnant or lactating women.
  • History of other malignancy within the past 3 years except with early stage/localized cancer that was surgically resected within the past 3 years.
  • Life expectancy <12 weeks.
  • Inability to comply with study and/or follow-up procedures.
  • History of peripheral neuropathy. There is no exclusion of patients based on sex, ethnicity or race. For these reasons, the study results are expected to be generalizable to the Medicare beneficiary population.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04891289


Contacts
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Contact: Andrea Cercek, MD 646-888-4189 cerceka@mskcc.org
Contact: William Jarnagin, MD 212-639-7601

Locations
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United States, Missouri
Washington University (Data Collection Only) Recruiting
Saint Louis, Missouri, United States, 63110
Contact: William Chapman, MD    314-362-2538      
United States, New Jersey
Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Andrea Cercek, MD    646-888-4189      
Principal Investigator: Andrea Cercek, MD         
Memorial Sloan Kettering Monmouth - Limited Protocol Activities Recruiting
Middletown, New Jersey, United States, 07748
Contact: Andrea Cercek, MD    646-888-4189      
Memorial Sloan Kettering Bergen - Limited Protocol Activities Recruiting
Montvale, New Jersey, United States, 07645
Contact: Andrea Cercek, MD    646-888-4189      
United States, New York
Memorial Sloan Kettering Commack - Limited Protocol Activities Recruiting
Commack, New York, United States, 11725
Contact: Andrea Cercek, MD    646-888-4189      
Principal Investigator: Andera Cercek, MD         
Memoral Sloan Kettering Westchester - Limited Protocol Activities Recruiting
Harrison, New York, United States, 10604
Contact: Andrea Cercek, MD    646-888-4189      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andrew Cercek, MD    646-888-4189      
Memorial Sloan Kettering Nassau - Limited Protocol Activities Recruiting
Uniondale, New York, United States, 11553
Contact: Andrea Cercek, MD    646-888-4189      
United States, North Carolina
Duke University (Data Collection Only) Recruiting
Durham, North Carolina, United States, 27710
Contact: Michael Lidsky, MD    919-660-9673      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Andrea Cercek, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04891289    
Other Study ID Numbers: 20-348
First Posted: May 18, 2021    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Memorial Sloan Kettering Cancer Center:
Gemcitabine
Oxaliplatin
Floxuridine
Dexamethasone Pump
20-348
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Dexamethasone
Oxaliplatin
Floxuridine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors