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Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Biliary Tract Cancer

Intervention: Abraxane (Nab-Paclitaxel) (Drug); Cisplatin (Drug); Gemcitabine (Drug); Phone Calls (Behavioral)

Phase: Phase 2

Status: Recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Rachna Shroff, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
Rachna Shroff, MD, Phone: 713-792-2828

Summary

The goal of this clinical research study is to learn if adding abraxane (nab-paclitaxel) to gemcitabine and cisplatin can help to control metastatic or unresectable biliary cancer. The safety of this drug combination will also be studied.

Clinical Details

Official title: A Phase II Study of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers

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

Primary outcome: Progression-Free Survival (PFS) of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers

Secondary outcome: Response Rate (RR) of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers

Detailed description: Study Drug Administration: If participant is found to be eligible to take part in this study, they will receive the study drugs in 21-day study cycles. Participant will receive all 3 drugs by vein on Days 1 and 8 of each cycle over about 2 hours total. Participant will receive abraxane first, followed by cisplatin, and then gemcitabine. Study Visits: On Days 1 and 8 of each cycle:

- Participant will have a physical exam.

- Blood (about 2 tablespoons) will be drawn for routine tests.

At the end of every 3rd cycle (Cycles 3, 6, 9, and so on), participant will have MRI or CT scans. If the disease appears to get better, participant will have another scan about 3 cycles later. Length of Study: Participant may continue taking the study drugs for as long as the doctor thinks it is in their best interest. Participant will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions. Patient's participation on the study will be over after the last scan during long-term follow-up. End-of-Treatment Visit: Within 10 days after participant stops taking the study drugs:

- Participant will have a physical exam.

- Blood (about 2 tablespoons) will be drawn for routine tests.

- If participant has not had one in the last 4 weeks, they will have MRI or CT scans.

Follow-Up: About 30 days after participant's last dose of the study drugs, the study staff will ask about any symptoms or side effects they may be having, either by phone or during a routine clinic visit. If participant is called, it should last about 15-30 minutes. Long-Term Follow-Up: About every 12 weeks after the end-of-treatment visit, if participant leaves the study for any reason other than the disease getting worse, they will have an MRI or CT scan to check the status of the disease. If participant starts receiving other anti-cancer treatment, they will stop having these scans. The study staff will also review participant's medical records and/or call participant to check the status of the disease every 3 months after they stop receiving the study drugs. If participant is called, it should take about 5 minutes. This is an investigational study. Abraxane is FDA approved and commercially available for the treatment of melanoma, breast, pancreatic, and lung cancer. The use of abraxane in patients with biliary cancer is considered investigational. Gemcitabine is FDA approved and commercially available for the treatment of ovarian, biliary, and pancreatic cancer. Cisplatin is FDA approved and commercially available for the treatment of osteosarcoma, lung cancer, biliary cancer, and malignant fibrous histiocytoma. Up to 50 participants will be enrolled in this multicenter study. Up to 40 will take part at MD Anderson.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patient must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer or may undergo a repeat biopsy for histologic confirmation if pre-existing biopsy is not sufficient for diagnosis. 2. Metastatic or unresectable disease documented on diagnostic imaging studies. 3. May not have received prior chemotherapy. If patient has received prior adjuvant therapy, must be > 6 months from treatment. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. 5. Adequate organ function including: a) Absolute neutrophil count (ANC) =/>1,500 cells/mm^3; b) Platelets =/>100,000/ul; c) Hemoglobin >9. 0 g/dL; d) Total bilirubin =/<1. 5mg/dL (In patients with known Gilbert's syndrome direct bilirubin =/<1. 5 x ULN will be used as organ function criteria, instead of total bilirubin; e) AST and ALT < 2. 5 x ULN; f) Alkaline phosphatase <2. 5x ULN; g) Creatinine <1. 5 gm/dL 6. Negative serum or urine pregnancy test in women with childbearing potential (WOCBP) defined as not post-menopausal for 12 months or no previous surgical sterilization, within one week prior to initiation of treatment. WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy. 7. A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study and for up to 12 weeks after the last dose of study drug to minimize the risk of pregnancy. If the partner is pregnant or breastfeeding, the subject must use a condom. 8. Patients must sign an Informed Consent and Authorization indicating that they are aware of the investigational nature of this study and the known risks involved. 9. Patient is =/>18 years of age on the day of consenting to the study. Exclusion Criteria: 1. Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4. 0. In CTCAE version 4. 0 grade 2 sensory neuropathy is defined as "moderate symptoms; limiting instrumental activities of daily living (ADLs)" 2. Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, uncontrolled diabetes, serious active or uncontrolled infection. 3. Pregnancy (positive pregnancy test) or lactation. 4. Known CNS disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.

Locations and Contacts

Rachna Shroff, MD, Phone: 713-792-2828

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: April 2015
Last updated: April 6, 2015

Page last updated: August 23, 2015

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