Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers
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| ClinicalTrials.gov Identifier: NCT02392637 |
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Recruitment Status :
Active, not recruiting
First Posted : March 19, 2015
Last Update Posted : July 24, 2018
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The goal of this clinical research study is to learn if adding abraxane (nab-paclitaxel) to gemcitabine and cisplatin can help to control metastatic (has spread) or unresectable (cannot be removed by surgery) biliary cancer. The safety of this drug combination will also be studied.
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 60 participants will be enrolled in this multicenter study. Up to 50 will take part at MD Anderson.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Biliary Tract Cancer | Drug: Abraxane (Nab-Paclitaxel) Drug: Cisplatin Drug: Gemcitabine Behavioral: Phone Calls | Phase 2 |
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive the study drugs in 21-day study cycles.
You will receive all 3 drugs by vein on Days 1 and 8 of each cycle over about 2 hours total. You will receive abraxane first, followed by cisplatin, and then gemcitabine.
Study Visits:
On Days 1 and 8 of each cycle:
- You 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), you will have MRI or CT scans. If the disease appears to get better, you will have another scan about 3 cycles later.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the last scan during long-term follow-up.
End-of-Treatment Visit:
Within 10 days after you stop taking the study drugs:
- You will have a physical exam.
- Blood (about 2 tablespoons) will be drawn for routine tests.
- If you have not had one in the last 4 weeks, you will have MRI or CT scans.
Follow-Up:
About 30 days after your last dose of the study drugs, the study staff will ask about any symptoms or side effects you may be having, either by phone or during a routine clinic visit. If you are called, it should last about 15-30 minutes.
Long-Term Follow-Up:
About every 12 weeks after the end-of-treatment visit, if you leave the study for any reason other than the disease getting worse, you will have an MRI or CT scan to check the status of the disease. If you start receiving other anti-cancer treatment, you will stop having these scans.
The study staff will also review your medical records and/or call you to check the status of the disease every 3 months after you stop receiving the study drugs. If you are called, it should take about 5 minutes.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 62 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Study of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers |
| Actual Study Start Date : | April 2, 2015 |
| Estimated Primary Completion Date : | April 2019 |
| Estimated Study Completion Date : | April 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Gemcitabine + Cisplatin + Abraxane (Nab-Paclitaxel)
All 3 drugs administered intravenously on Day 1 and Day 8 of the cycle. Nab-Paclitaxel given at 100 mg/m2, followed by Cisplatin at 25 mg/m2 and then Gemcitabine at 800 mg/m2 for 2 weeks in a row followed by a week of rest. Cycles are 21 days. Participant receives phone call from study staff 30 days after last dose of study drugs, and every 12 weeks thereafter. |
Drug: Abraxane (Nab-Paclitaxel)
100 mg/m2 by vein on Day 1 and Day 8 of a 21 day cycle.
Other Names:
Drug: Cisplatin 25 mg/m2 by vein on Day 1 and Day 8 of a 21 day cycle.
Other Names:
Drug: Gemcitabine 800 mg/m2 by vein on Day 1 and Day 8 of a 21 day cycle.
Other Names:
Behavioral: Phone Calls Participant receives phone call from study staff 30 days after last dose of study drugs, and every 12 weeks thereafter. |
- Progression-Free Survival (PFS) of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers [ Time Frame: 63 days ]Response and progression evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1, 2009). The Bayes factor single arm time-to-event model by Johnson & Cook will be used to monitor the PFS time.
- Response Rate (RR) of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers [ Time Frame: 63 days ]Response rate defined as partial response (PR), complete response (CR), and stable disease (SD). PR: At least a 30% decrease in sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. PR: At least a 30% decrease in sum of (LD) of target lesions taking as reference the baseline sum LD. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started.
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- Metastatic or unresectable disease documented on diagnostic imaging studies.
- May not have received prior chemotherapy. If patient has received prior adjuvant therapy, must be > 6 months from treatment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- 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 =/< 5 x ULN; f) Creatinine =/<1.5 gm/dL
- 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.
- 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.
- 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.
- Patient is =/>18 years of age on the day of consenting to the study.
Exclusion Criteria:
- 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)"
- 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.
- Pregnancy (positive pregnancy test) or lactation.
- 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.
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): NCT02392637
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55902 | |
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Milind Javle, MD | M.D. Anderson Cancer Center |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT02392637 History of Changes |
| Other Study ID Numbers: |
2014-0524 NCI-2015-00578 ( Registry Identifier: NCI CTRP ) |
| First Posted: | March 19, 2015 Key Record Dates |
| Last Update Posted: | July 24, 2018 |
| Last Verified: | July 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Biliary Tract Cancer Intrahepatic cholangiocarcinoma Extrahepatic cholangiocarcinoma, Gallbladder cancer Metastatic Unresectable Abraxane Nab-Paclitaxel Paclitaxel (Protein-Bound) |
ABI-007 Cisplatin Platinol-AQ Platinol CDDP Gemcitabine Gemcitabine Hydrochloride Gemzar Phone calls |
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Biliary Tract Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Biliary Tract Diseases Digestive System Diseases Gemcitabine Paclitaxel Albumin-Bound Paclitaxel Cisplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |