Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Therasphere is a form of treatment that has been designed to selectively deliver radiation to the cancer within the patient's liver. This form of treatment has been used in a number of clinical trials and has been approved for use in the treatment of liver cancer.
The investigators want to test the safety of using Gemcitabine (a chemotherapy drug) with TheraSphere (radioactive beads that are injected directly into the blood vessel supplying the tumor in the liver) in patients with advanced pancreatobiliary tumors such as pancreatic cancer or cholangiocarcinoma (bile duct tumors) involving the liver.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Neoplasms Cholangiocarcinoma |
Drug: Gemcitabine with TheraSphere |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Trial of Gemcitabine With TheraSphere® (Yttrium-90) in Patients With Hepatic Tumors of Pancreatobiliary Origin |
- The maximum tolerated dose of gemcitabine when given in combination with therasphere [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Patients will receive full dose therasphere. The gemcitabine dose will start out low and the dose will increase after first 3 patients if no significant side effects are observed. The investigators will continue to increase the dose of gemcitabine as long as the investigators do not observe side effects or until we reach full dose of gemcitabine.
- Toxicities (side effects) experienced by patients on the trial [ Time Frame: 90 days ] [ Designated as safety issue: No ]Any side effect experienced on the trial will be graded according to the grading system developed by the national cancer institute. The number of patients with each side effect will be calculated.
- Tumor response rate when treated with gemcitabine and Therasphere using CT scan and F18-FDG-PET scan . [ Time Frame: 78 days ] [ Designated as safety issue: No ]Patients will receive a PET CT prior to treatment and then another PET CT scan at completion day 78. Comparison of tumor size and uptake of FDG will be performed using standard RECIST criteria
- The progression free of patients treated on the trial [ Time Frame: 12 months ] [ Designated as safety issue: No ]The investigators will follow patients with serial cross sectional (CT or MRI) scans. If the tumor shows growth on the scan then the investigators will calculate the time it took for the tumor to grow.
| Estimated Enrollment: | 24 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Gemcitabine with TheraSphere |
Drug: Gemcitabine with TheraSphere
Gemcitabine dose will be escalated and combined with therasphere.
Other Names:
|
Detailed Description:
Patients with liver predominant cholangiocarcinoma or pancreatic cancer will be considered for the trial. The patients wre being treated in groups of thre patients. Each three patients receive a pre-specified dose of gemcitabine with full dose radioembolization using theraspheres. If no significant side effects are observed then three additional three patients will be treated with a higher dose of gemcitabine. The purpose to identify the highest dose of gemcitabine that can be safely combined with theraspheres.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologic or cytologic diagnosis of pancreatic cancer or cholangiocarcinoma
Liver predominant disease defined as
- Cholangiocarcinoma: liver disease should be unresectable
- Limited extra hepatic metastasis defined as: i. Lung metastasis: 6 or less nodules with no nodule greater than 1.5 cm.
ii. Abdominal lymph nodes iii. Pancreatic primary as long as the size is less than 4 cm in size iv. Bone metastasis
- No prior systemic therapy for advanced stage disease
- Measurable target tumors using standard imaging techniques
- Lung shunting less than 20%
- ECOG performance status 0-1 (See Appendix )
- Age ≥ 18 years
- No other investigational agents while on protocol
- Signed informed consent
Exclusion Criteria:
- Inadequate hepatic function: AST/ALT > five times upper limit of normal, Bilirubin >2.0 mg/dl or history of hepatic encephalopathy
- Inadequate renal function Creatinine > 2.0 mg/dL
- Inadequate bone marrow function: platelets < 100,000/mL or absolute neutrophil count <1500/mL
- Contraindication to angiography
- Prior external beam radiotherapy to the upper abdomen
- Clinical evidence of peritoneal metastasis or ascites
- Patients with extensive tumor replacement in the liver defined as >50% of liver involved with tumor
- Any serious ongoing extra-hepatic disease such as infections.
Contacts and Locations| Contact: Hyun Kevin Kim, MD | 1-888-946-7447 | hkim286@emory.edu |
| Contact: Bassel F El-Rayes, MD | 1-888-946-7447 | bassel.el-rayes@emoryhealthcare.org |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Hyun Kim, MD 888-946-7447 | |
| Principal Investigator: Hyun Kim, MD | |
| Principal Investigator: | Hyun Kevin Kim, MD | Emory University Winship Cancer Institute |
| Principal Investigator: | Bassel El-Rayes, MD | Emory University Winship Cancer Institute |
More Information
No publications provided
| Responsible Party: | Hyun Kevin Kim, MD, Emory University |
| ClinicalTrials.gov Identifier: | NCT01434459 History of Changes |
| Other Study ID Numbers: | WCI1907-10 |
| Study First Received: | September 12, 2011 |
| Last Updated: | December 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
Pancreatic neoplasms Cholangiocarcinoma |
Additional relevant MeSH terms:
|
Neoplasms Liver Neoplasms Pancreatic Neoplasms Cholangiocarcinoma Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Gemcitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 19, 2013