
The Clinical Trials results are the experiments done in the past to see if the drug works, and how well, and for how long.  There is a list of all clinical trials using Gemcitabine on the NCI PDQ Database.

<b>Current Clinical Trials with Gemcitabine</b>
From the &&url 
Go to the "Type Of Cancer" search window, and select either Soft Tissue Sarcoma [adult] or Uterine Sarcoma
Find the Drug selection window 
Browse the drug list, and select the drug [so you don't have spelling problems].
Go to the bottom of the page, and click on "search now"
The Search Result page will appear.
If you click on the title of the Study, more information about the study will appear.


<b>PubMed Searches
Directions for use:</b>
When you click on the search string, it will connect you to Pubmed and display the first 20 citations [which they will call Summaries].  What you WANT is the complete listing of all the summaries of the article [which they will call Abstracts. ]  

Go to the second toolbar, and use the drop down menu to change summaries to Abstracts,  and 20 to 200,  and sort by DATE, and then click on DISPLAY on that same toolbar.  You may have to wait while the page loads.

NOW you can save this search to a folder on your hard drive as "GemzarClinicalTrials" as an HTML file - or as a text file.  The entire file, or just those parts which you wish to discuss, can be printed out and taken to talk over with your doctor.</b>


Search Pubmed for &&url

Search Pubmed for &&url

Search Pubmed for &&url

Search Pubmed for &&url


ASCO Searches

You will have to go to the site and search year by year with keywords of the chemotherapy agent AND sarcoma.

&&url

The results of a partial search are listed below.
ASCO medical abstracts are all under copyright.  Use the links to view the complete & detailed abstracts.  You may make one copy of any copyrighted article for your personal use.


<b>A Phase II Trial of Gemcitabine, Paclitaxel and Carboplatin in Stage IVB Soft Tissue Sarcoma.</b>
Responses of 5 sarcoma patients in a phase I study prompted further investigation. ... A complete response in one angiosarcoma [for 6 months], there was one partial response, and 7 stable disease [9/22 = 41%]. The regimen is not without hemotological or hepatic toxicity. 
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<b>Docetaxel (D) Plus Gemcitabine (G) is Active in Leiomyosarcoma (LMS): Results of a Phase II Trial. </b>
16 evaluable patients: 3 CR, 5 PR [50% decrease in lesion size]= 50% Response Rate. Most were ULMS, and many had been unresponsive to doxo and ifos. Toxicity: bone marrow, dyspnea, fatigue, neurotoxity
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<b>Phase I Study of Low Dose Continuous Infusion Gemcitabine in Sarcoma Patients.</b>
The conversion of gemcitabine to its triphosphate is rate limiting, and proceeds equivalently to 10mg/m2/min IV. 
9 Phase I patients with refractory STS were given gemcitabine as a 72 hour infusion, every 2 weeks. Dose escalation was 50, 75, 100, 150 mg/m2, increasing every 2 cycles [in the absence of toxicity]. 
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<b>Phase I Pharmacokinetic Trial of the Farnesyl Transferase Inhibitor SCH66336 Plus Gemcitabine in Advanced Cancers. </b>
"Farnesyl transferase inhibitors (FTI) are a new class of drugs that inhibit post-translational C-terminal modification of many essential proteins including ras, rac, rho and most cellular g-proteins. SCH 66336 is a potent, orally bioavailable FTI that possesses in vivo and in vitro activity against a wide variety of human tumor... cell lines and xenografts." "SCH66336 and gemcitabine has led to an impressive disease stability in a variety of refractory solid tumors" 
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<b>Phase I Study of the Combination of Taxotere, Gemcitabine and CPT 11 in Patients with Refractory Malignancies.</b>
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<b>A Phase I Trial of Gemcitabine (GEM) and Paclitaxel (PAC) in Patients with Advanced Solid Tumors, Administered Every 21 Days (LOA-2). </b> One patient with a soft tissue sarcoma achieved partial response. 
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<b>Phase I Trial of Three-Hour Infusion Gemcitabine (GEM) (Days 1,8,15 Every 28) in Refractory, Heavily Pretreated (HP) Advanced Solid Tumors. </b>
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<b>Biweekly Docetaxel (DOC), Gemcitabine (GEM) and Oxaliplatin (LOHP) in Pretreated Patients with Solid Tumors. Results of a Phase I Study. </b>
31 patients, 5 sarcoma. 22pts evaluable for efficacy: PR5 [23%] SD 13 [59%]; progressive disease 4 [18%].
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<b>RFS 2000 (9-NC) with Short or Constant Rate Infusion Gemcitabine (GEM) in Patients (Pts) with Refractory Tumors.</b>
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<b>Phase I Study of Gemcitabine and Docetaxel for Locally Advanced and/or Metastatic Cancer of the Head and Neck, Non-Colorectal Gastrointestinal Cancer, Hepatoma, and Soft Tissue Sarcoma. </b>
"The maximum-tolerated-dose of docetaxel with gemcitabine is 70mg/m2 and a phase II study in selected primary sites is planned." 
&&url

<b>Limited Activity and Acceptable Toxicity of Gemcitabine in a Phase II Study of Patients (Pts) with Advanced Sarcomas: A Mayo Cancer Center Study. </b>
We evaluated gemcitabine in pts having histologically confirmed sarcomas. 26 of 30 pts are evaluable. There were 9 leiomyosarcoma (5-GI, 3-intrabdominal, 2-IVC, 2-extremity, and 2-uterine) "1% of pts have progressed and 23% have died. 77% of pts discontinued treatment due to progression and 12% due to toxicity/refusal. One partial response was observed in a uterine leiomyosarcoma pt lasting at least 3 months. Overall response rate is 3%." "This regimen is not recommended for advanced sarcomas."
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<b>Biweekly Docetaxel (Doc), Gemcitabine (Gem), Oxaliplatin (LOHP) in Heavily Pretreated Patients with Solid Tumors-A Pilot Study. </b>
10 pts with refractory tumors, 8 evaluable for response, 2/8 objective remissions [the only sarcoma], 4/8 other clinical response
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<b>Gemcitabine, Carboplatin, and Paclitaxel: An Active, Tolerable Treatment for Advanced Malignancy. </b>
"Of the 14 patients evaluable for response, only two patients demonstrated progressive disease after two cycles. 6/14 patients had objective evidence of response, including one CR (bladder), two PRs (1 pretreated bladder, 1 heavily pretreated sarcoma), and three minimal responses (MRs) (pretreated sarcoma, bladder and prostate)."... 
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<b>Preliminary Results of a Two-Arm Phase 2 Trial of Gemcitabine (Gem) in Patients (Pts) with Gastrointestinal Leiomyosarcomas (leios) and Other Soft-Tissue Sarcomas (STS). </b>Two groups: 14 GI leios and 16 other STS.  STS: 1 CR (angiosarcoma), 2 PRs (uterine leios), and 1 MR (extremity leio)= 4/16 RR. TTP is 9+ mo for the CR and 4+ and 5 mo for the PRs.  GI leio : 1 mixed response. 
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<b> Gemcitabine in Patients with Sarcoma of Soft Tissue or Bone Resistant to Standard Chemotherapy. </b>
"Objective responses were minimal to partial in 2/13 (STS: Angiosarcoma, leiomyosarcoma) stabilization in 3/13 (BS). Time to progression was 4--45(+) w, median 8(+)w. Conclusions:gemcitabine is worth-studying in patients with sarcomas, refractory to standard chemotherapy." 
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<b>Severe Nonhematologic Toxicity After Treatment with Gemcitabine. 
Discussion of cardiac and pulmonary toxicity with Gemcitabine. </b>&&url

<b>GEMCITABINE (GEM) IN PRETREATED PATIENTS WITH ADVANCED SOFT TISSUE SARCOMAS (STS) ---PRELIMINARY RESULTS FROM A PHASE II TRIAL. </b>
"According to recent preliminary data prolonged infusion of GEM might be superior to the brief 30-minute infusions that have been used in most phase IItrials (J Clin Oncol 15:2172, 1997). " "Using GEM (200 mg/m2) as a 360-minute infusion on days 1, 8, 15 of a 28 day cycle in heavily pretreated pts with advanced STS". Ten pts evaluable for response produced 2 partial remissions and 3 SD. 
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compiled by doctordee
updated October 2003
