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Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients with Sensitive Small Cell Lung Cancer (SCLC) Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients with Sensitive Small Cell Lung Cancer (SCLC) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients with Sensitive Small Cell Lung Cancer (SCLC) Clinical research trials and Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients with Sensitive Small Cell Lung Cancer (SCLC) medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients with Sensitive Small Cell Lung Cancer (SCLC). Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients with Sensitive Small Cell Lung Cancer (SCLC) Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients with Sensitive Small Cell Lung Cancer (SCLC) clinical trial. Participants frequently obtain the most expert healthcare available for their Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients with Sensitive Small Cell Lung Cancer (SCLC) condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients with Sensitive Small Cell Lung Cancer (SCLC)  Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients with Sensitive Small Cell Lung Cancer (SCLC)
Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients with Sensitive Small Cell Lung Cancer (SCLC)
For Condition: Small Cell Lung Cancer
Status: Recruiting
Sponsor(s): Biomeasure Inc, Ipsen Group ,
Synopsis: This is a Phase II, open-label, multicenter, single-arm, exploratory “proof of concept” study. Diflomotecan (7 mg fixed dose) will be administered as a 20-minute IV infusion once every 3 weeks in patients with sensitive small cell lung cancer (SCLC) with progressive disease after first-line treatment with a platinum-based regimen.
Details:
Eligibility:
Study Type: Interventional,Treatment,Non-Randomized,Open Label,Uncontrolled,Single Group Assignment,Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Histologically or cytologically documented small cell lung cancer (SCLC) - One measurable lesion according to RECIST criteria, not included in a previously irradiated region - Received one and no more than one previous line of chemotherapy for SCLC, including any platinum analogue, and excluding any camptothecin analogues. The patient must have experienced objective response to this first-line regimen and relapsed after a treatment free interval of no less than 3 months - Expected life expectancy of greater than 3 months - A WHO performance status score of 0 or 1 - Free of serious intercurrent disease - Adequate bone marrow function, liver function and renal function - For patients present with with brain metastases, their neurologic symptoms must be adequately controlled by radiotherapy or steroid treatment and the patient must have other sites of measurable disease - No investigational (either anti-cancer or not)/commercial agents or therapies other than diflomotecan may be administered with the intent to treat the patient’s malignancy in the timeframe of the study treatment, - Any pre-existing extensive palliative or curative radiotherapy must be stopped for at least two weeks before study treatment onset. The patient must have fully recovered from any toxicity Exclusion Criteria: - Pregnant or lactating; or is at risk of pregnancy during the study or is not taking adequate precautions against pregnancy - Known hypersensitivity to any of the test materials or related compounds - In the opinion of the investigator, unable and/or unwilling to comply fully with the protocol and the study instructions - With any concomitant condition which could compromise the objectives of this study or the patient’s compliance (e.g. symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements) - Clinical evidence of major organ failure, or presents with an active or uncontrolled intercurrent illness at time of entry in the study, including but not limited to, ongoing or active infection and unstable angina pectoris - Previously received any bone marrow transplantation (BMT) or any peripheral blood progenitor cells (PBPC) - Has had major surgery within 4 weeks of entering the study - Has suffered from another cancer including haematological malignancy within the last 10 years, unless it was a curatively treated non melanoma skin cancer or an in situ carcinoma of the cervix, or the patient has any other active cancer. In case of prior cancer, other than curatively treated non-melanoma skin cancer or an in situ carcinoma of the cervix, all attempts, including new biopsy/cytology should be performed to exclude the relapse of this cancer - Likely to receive any other anti-cancer treatment during the treatment phase of the trial, or received such a treatment in the preceding 2 weeks, or the patient has not completely recovered from any toxicity of such treatment - currently participating in a clinical trial or plans to participate in another clinical trial during the treatment phase of this study, or has participated in a clinical trial in the previous 30 days of inclusion
Total Enrollment: 40
Location and Contact Information:
Klinische Abteilung für Oncologie, Universitäts-Klinik für Innere Medizin I *Recruiting*
Wien, , A-1090
Austria
Recruiting Pr PIRKER 43 1 40400 4466
CHU Arnaud de Villeneuve *Recruiting*
Montpellier, , 34295
France
Recruiting Pr PUJOL 33 4 67 33 61 35
Hospital Germans Trias i Pujol *Not yet recruiting*
Barcelona, , 08916
Spain
Not yet recruiting Pr ROSELL 34 934 65 1200
Anschutz Cancer Pavilion at Universitty of Colorado Health Sciences Center *Not yet recruiting*
Aurora, Colorado, 80010
United States
Not yet recruiting Lyn Magree 720-848-0676
Institut Claudius Regaud *Recruiting*
Toulouse, , 31300
France
Recruiting Dr CAUNES 33 5 61 42 41 14
Institut Gustave ROUSSY *Recruiting*
Villejuif, , 94800
France
Recruiting Pr LECHEVALIER 33 1 42 11 43 17
Hospital Duran i Reynals *Not yet recruiting*
Barcelona, , 08902
Spain
Not yet recruiting Dr CARDENAL-ALEMANY 34 9 333 57652, ext 3071/ 3385
Hillman Cancer Center, University of Pittsburgh Cancer Institute *Not yet recruiting*
Pittsburgh, Pennsylvania, 15236
United States
Not yet recruiting Kristin Vitalone 412-623-4897
Fletcher Allen Health Care, University of Vermont *Recruiting*
Burlington, Vermont, 05401
United States
Recruiting Cecile Rohrbach 802-656-9924
AK St. Georg *Not yet recruiting*
Hamburg, , D-20099
Germany
Not yet recruiting Prof. A.R. HANAUSKE 49 40 2890 2281
Fox Chase Cancer Center *Not yet recruiting*
Philadelphia, Pennsylvania, 19111
United States
Not yet recruiting Schol Jessie 215-728-2769
Asklepios-Fachkliniken München-Gauting *Not yet recruiting*
Gauting, , D-82131
Germany
Not yet recruiting Dr. von PAWEL 49 89 85791 2011
Ltd. Oberarzt Innere Klinik und Poliklinik *Not yet recruiting*
ESSEN, , D-45122
Germany
Not yet recruiting Prof. med. Max E. SCHEULEN 49 201 723 3153 / 3245
University of Chicago Medical Center *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Szeto Livia 773-834-0783
Dana-Farber cancer Institute & Massachusetts General Hospital *Not yet recruiting*
Boston, Massachusetts, 02115
United States
Not yet recruiting McKenna Christine 617-632-5290
US Gasthuisberg *Recruiting*
Leuven, , 3000
Belgium
Recruiting Dr NACKAERTS +32 16 346 802
Additional Information:
Study ID Numbers: Ipsen Protocol 2-91-52990-708;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080015
Other Small Cell Lung Cancer Studies:
1. Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases
2. Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients with Sensitive Small Cell Lung Cancer (SCLC)
3. Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer
4. Isotretinoin With or Without Vitamin E for Prevention of Lung Cancer
5. Inositol in Preventing Lung Cancer in Patients With Bronchial Epithelial Dysplasia Who Are Current or Former Smokers
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Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients with Sensitive Small Cell Lung Cancer (SCLC)
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