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Gemzar (Gemcitabine Hydrochloride) - Summary

 
 



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.


See all Gemzar indications & dosage >>

NEWS HIGHLIGHTS

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.

more studies >>

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.

more trials >>

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 >>


Page last updated: 2015-08-10

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