GEMZAR SUMMARY
Gemzar® (gemcitabine HCl) is a nucleoside analogue that exhibits antitumor activity. Gemcitabine HCl is 2′-deoxy-2′,2′-difluorocytidine monohydrochloride (β–isomer).
Therapeutic Indications
Ovarian Cancer
Gemzar in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum–based therapy.
Breast Cancer
Gemzar in combination with paclitaxel is indicated for the first–line treatment of patients with metastatic breast cancer after failure of prior anthracycline–containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
Non–Small Cell Lung Cancer
Gemzar is indicated in combination with cisplatin for the first–line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non–small cell lung cancer.
Pancreatic Cancer
Gemzar is indicated as first–line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemzar is indicated for patients previously treated with 5–FU.
|
NEWS HIGHLIGHTSMedia Articles Related to Gemzar (Gemcitabine)
First-line Doxorubicin for Advanced Sarcoma, Not Combo? Source: Medscape Hematology-Oncology Headlines [2017.09.27] Doxorubicin should remain first-line therapy for patients with soft-tissue sarcoma, conclude trialists who compared it with a gemcitabine and docetaxel combination. Medscape Medical News
Published Studies Related to Gemzar (Gemcitabine)
Randomized phase III trial of gemcitabine plus docetaxel plus bevacizumab or
placebo as first-line treatment for metastatic uterine leiomyosarcoma: an NRG
Oncology/Gynecologic Oncology Group study. [2015] progression-free survival (PFS) in uLMS... CONCLUSION: The addition of bevacizumab to gemcitabine-docetaxel for first-line
Randomized double-blinded, placebo-controlled phase II trial of simvastatin and
gemcitabine in advanced pancreatic cancer patients. [2014] placebo (GP) in patients with locally advanced and metastatic pancreatic cancer... CONCLUSIONS: Adding low-dose simvastatin to gemcitabine in advanced pancreatic
Sorafenib or placebo with either gemcitabine or capecitabine in patients with
HER-2-negative advanced breast cancer that progressed during or after
bevacizumab. [2013] CONCLUSION: The addition of sorafenib to gemcitabine/capecitabine provided a
Pharmacodynamic stimulation of thrombogenesis by angiotensin (1-7) in recurrent
ovarian cancer patients receiving gemcitabine and platinum-based chemotherapy. [2013] scheduled dose intensity were also determined... CONCLUSIONS: A 100 mcg/kg dose of A(1-7) was shown to produce pharmacodynamic
Cationic liposomal paclitaxel plus gemcitabine or gemcitabine alone in patients with advanced pancreatic cancer: a randomized controlled phase II trial. [2011.09.06] BACKGROUND: Paclitaxel embedded in cationic liposomes (EndoTAG-1; ET) is an innovative agent targeting tumor endothelial cells. This randomized controlled phase II trial evaluated the safety and efficacy of ET in combination with gemcitabine (GEM) in advanced pancreatic cancer (PDAC)... CONCLUSIONS: Treatment of advanced PDAC with GEM + ET was generally well tolerated. GEM + ET showed beneficial survival and efficacy. A randomized phase III trial should confirm this positive trend.
Clinical Trials Related to Gemzar (Gemcitabine)
Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer [Completed]
This study will evaluate the efficacy and tolerability of the combination of Gleevec and
Gemzar in patients with ovarian cancer, who have progressed after receiving at least one
prior chemotherapy treatment. Gleevec is an oral chemotherapy drug used is this study and
Gemzar is an IV chemotherapy drug used. Participation in the treatment portion of the study
will continue as long as the patient's tumors shrink or remain stable and as long as the
patient is able to tolerate the study drug. The follow-up portion of the study will last
for 5 years.
Intrathecal Gemcitabine to Treat Neoplastic Meningitis, IT Gemcitabine [Terminated]
Subject's are being asked to take part in this study because he or she has a type of cancer
that has spread to the meninges (tissues that cover the brain and spinal cord).
There is no known effective treatment for this specific disease or the subject has received
all of the treatments that are known to work for his or her specific disease without
success. Currently, there is no other effective treatment for this type of cancer.
The purposes of this study are:
- to determine the highest dose of gemcitabine, an anti-cancer drug, that can safely be
given directly into the spinal fluid of children and adults whose cancer no longer
responds to standard treatment;
- to find out what effects (good and bad) gemcitabine has when given directly into the
cerebrospinal fluid (called intrathecal administration) in children and adults with
neoplastic meningitis (cancer that has spread to the lining of the brain and spinal
cord);
- to determine if gemcitabine is beneficial to the patient;
- to understand how gemcitabine is handled by the body after intrathecal administration.
Gemcitabine/Clofarabine/Busulfan and Allogeneic Transplantation for Aggressive Lymphomas [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of
gemcitabine (out of 6 possible doses) that can be given in combination with busulfan and
clofarabine before an allogeneic stem cell transplant. Researchers also want to learn if
this combination can help to control lymphoma. The safety of this treatment will also be
studied.
Busulfan is designed to bind to DNA (the genetic material of cells), which may cause cancer
cells to die. It is commonly used in stem cell transplants.
Clofarabine and gemcitabine are designed to block the growth of cancer cells, which may
cause the cancer cells to die.
PP-Gemcitabine & External Beam Radiation-Sarcomas [Completed]
The goal of this clinical research study is to find the highest safe dose of gemcitabine
that can be given with radiotherapy before surgery to treat sarcoma. This study will also
look at how well this treatment controls sarcoma.
A Two-Dimensional Dose-Finding Study of Ixazomib in Combination With Gemcitabine and Doxorubicin, Followed by a Phase II Extension to Assess the Efficacy of This Combination in Metastatic, Surgically Unresectable Urothelial Cancer [Recruiting]
This clinical research study is made up of 2 phases.
The goal of Phase 1 of this study is to learn the highest tolerated dose of the combination
of ixazomib, gemcitabine, and doxorubicin that can be given to patients with urothelial
cancer.
The goal of Phase 2 of this study is to learn if the combination of ixazomib, gemcitabine,
and doxorubicin can help to control urothelial cancer.
The safety of the drug combinations will be studied in both phases.
Reports of Suspected Gemzar (Gemcitabine) Side Effects
Death (136),
Neoplasm Progression (100),
Interstitial Lung Disease (57),
Thrombocytopenia (32),
Anaemia (31),
Renal Failure Acute (28),
White Blood Cell Count Decreased (28),
OFF Label USE (26),
Pyrexia (25),
Decreased Appetite (24), more >>
|