Clinical Trials Logo

Clinical Trial Summary

This research study is evaluating a drug called cabozantinib as a possible treatment cancer of the bile duct. Cabozantinib is a drug that targets specific pathways inside the cells of the body. By blocking the c-MET and VEGFR2 pathways from sending signals, cabozantinib may prevent cells from multiplying. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to stop the growth of bile duct cancer.

In this research study, the investigators are looking to see how well cabozantinib works in slowing the growth of bile duct cancer. The investigators are also assessing the safety and tolerability of cabozantinib in participants with this type of cancer.


Clinical Trial Description

After the screening procedures confirm that the participants are eligible to participate in the research study:

A two-stage design will be employed in this study where at least 9 of the 20 patients enrolled in the first stage need to be progression-free at 16 weeks before the second stage can proceed. If this criterion is met, an additional 24 patients will be enrolled in the second stage for a total of 44 patients in the study. Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.

In this research study, the participant will be given a study drug-dosing diary for each treatment cycle. Each treatment cycle lasts 28 days (4 weeks), during which time the participant will be taking the study drug, cabozantinib daily. The diary will also include special instructions for taking the study drug(s).

The participant will continue to take cabozantinib for as long as it is tolerated without any unacceptable side effects and the cancer does not get worse.

The following tests and procedures will be done during the research study:

Cycle 1 - On days 1, 8 and 15

- Medical History

- Physical Exam including vital signs and height and weight

- Performance Status

- Review of side effects (day 8 and 15 only)

- Routine blood tests (day 8 and 15 only)

- TSH blood sample on day 1 only

Additional research procedures during Cycle 1:

- Biomarker blood sample (about 2 teaspoons of blood) on day 3 and day 14

Cycles 2-3 - On days 1 and 15

- Medical History

- Physical Exam including vital signs, height and weight

- Performance Status

- Review of side effects

- EKG - day 1 of each cycle ONLY

- Routine blood tests

- Urine test on Day 1 of each cycle ONLY

- Urine pregnancy test on day 1 of each cycle for women of childbearing potential

- TSH blood sample on day 1 only

Cycle 4 and Beyond: Day 1 ONLY

- Medical History

- Physical Exam including vital signs, height and weight

- Performance Status

- Review of side effects

- EKG

- Routine blood tests

- TSH blood sample on day 1 only

- Urine test

- Urine pregnancy test for women of childbearing potential

The following tests will be done every 2 cycles during the research study:

- CA 19-9 blood sample

- Tumor measurements

- Chest/Abdominal/Pelvic CT/MRI of your tumor

Planned Follow-up:

The participant will return to the clinic between 30-37 days after the last dose of cabozantinib for the following tests and procedures:

- Medical History

- Physical Exam including vital signs, height and weight

- Performance Status

- Review of side effects

- Routine blood tests

- CA 19-9 blood sample

- TSH blood sample ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01954745
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 2013
Completion date June 2016

See also
  Status Clinical Trial Phase
Recruiting NCT05678218 - Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
Active, not recruiting NCT03781934 - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations Phase 1/Phase 2
Completed NCT01938729 - Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma Phase 1
Completed NCT03230318 - Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma Phase 2
Recruiting NCT06239532 - HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma Phase 2
Not yet recruiting NCT05535647 - Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma Phase 2
Not yet recruiting NCT05009953 - Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer Phase 2
Terminated NCT02254681 - Low-Dose Radiation Therapy to the Whole Liver With Gemcitabine and Cisplatin in IHC Phase 2
Completed NCT01347333 - Stereotactic Body Radiotherapy for Liver Tumors N/A
Active, not recruiting NCT04526106 - REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT05285358 - Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases Phase 1
Completed NCT03320980 - RALPPS in Patients With Hilar and Intrahepatic Cholangiocarcinoma N/A
Withdrawn NCT05019677 - GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Advanced BTC Phase 2
Withdrawn NCT03801499 - Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma Phase 2
Completed NCT05489692 - HAIC Plus Targeted Therapy and/or PD-1 Inhibitors for Unresectable Intrahepatic Cholangiocarcinoma
Recruiting NCT06101277 - Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG) N/A
Active, not recruiting NCT01917370 - VEGF Signaling Promotes Cell Growth and Metastasis in Intrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway N/A
Withdrawn NCT01775280 - Response of Hepatic Tumors to Radioembolization Phase 2
Not yet recruiting NCT05342194 - Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study Phase 3
Active, not recruiting NCT05781958 - Cadonilimab Combined With Gem/Cis as First Line Therapy in Patients With Advanced ICC Phase 2