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| [ Print-friendly version ] |
| AGENDA: Randomised, double-blind trial of dacarbazine with or without Genasense® (oblimersen, G3139) in advanced melanoma |
| ISRCTN | ISRCTN34237167 |
| ClinicalTrials.gov identifier | NCT00518895 |
| Public title | AGENDA: Randomised, double-blind trial of dacarbazine with or without Genasense® (oblimersen, G3139) in advanced melanoma |
| Scientific title | A multicentre, randomised, double-blind study of dacarbazine with or without Genasense® in chemotherapy-naïve subjects with advanced melanoma and low lactate dehydrogenase (LDH) (The AGENDA Trial) |
| Acronym | AGENDA |
| Serial number at source | GM307 |
| Study hypothesis |
This study is being performed to prospectively determine whether dacarbazine plus Genasense® is significantly better than dacarbazine plus placebo in chemotherapy-naïve subjects with advanced melanoma and baseline lactate dehydrogenase (LDH) less than or equal to 0.8 x upper limit of normal (ULN). LDH is a biomarker strongly associated with improved outcomes in a recent trial of dacarbazine plus Genasense®.
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| Ethics approval |
USA: The University of Texas, M.D. Anderson Cancer Center, Office of Protocol Review, approved in July 2007
France: The Salvator Hospital, Comite de Protection des Personnes Sud-Mediterranee I, Marseille, approved in October 2007 Other sites will also obtain ethics approval before recruitment of participants. |
| Study design | Phase III, multicentre, randomised (1:1), double-blind, placebo-controlled, parallel-group trial. |
| Countries of recruitment | Australia, Austria, Canada, Czech Republic, France, Germany, Italy, Spain, Switzerland, United Kingdom, USA |
| Disease/condition/study domain | Melanoma |
| Participants - inclusion criteria |
1. At least 18 years of age, both males and females
2. Histologically confirmed diagnosis of melanoma 3. Progressive disease that is not surgically resectable, or metastatic Stage IV disease 4. Low LDH (defined as LDH less than or equal to 0.8 x ULN) 5. Chemotherapy naïve 6. Measurable disease 7. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 8. At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy 9. Adequate organ function |
| Participants - exclusion criteria |
1. Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense® treatment
2. Primary ocular or mucosal melanoma 3. Bone-only metastatic disease 4. History or presence of brain metastasis or leptomeningeal disease 5. Significant medical disease other than cancer 6. Organ allograft |
| Anticipated start date | 01/07/2007 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Completed |
| Patient information material | Not currently available, please refer to the contact details below to request additional information. |
| Target number of participants | 300 |
| Interventions |
Protocol therapy is administered in 21-day cycles for up to 8 cycles.
Subjects in the dacarbazine plus Genasense® group receive Genasense® 7 mg/kg/day by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1,000 mg/m^2 as a 60-minute intravenous infusion immediately following the conclusion of the Genasense® infusion. Subjects in the dacarbazine plus placebo group receive placebo (that is, locally available commercial 0.9% sodium chloride injection) by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1000 mg/m^2 as a 60-minute intravenous infusion immediately following the conclusion of the placebo infusion. In both treatment groups, subjects who are responding or have stable disease after 8 cycles of therapy may, at the Investigator's discretion, continue that same therapy for up to 8 additional cycles. |
| Primary outcome measure(s) | Progression-free survival and overall survival |
| Secondary outcome measure(s) |
1. Response rate
2. Durable response rate 3. Duration of response 4. Safety Follow-up every 2 months for up to 24 months from date of randomisation. |
| Sources of funding |
Genta Incorporated (USA)
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| Trial website | http://www.genta.com/agenda.html |
| Publications | Abstract: Bedikian AY, Agarwala SS, Gilles E, Itri L, Kay R, Garbe C. The AGENDA Study: A randomized, double-blind study of Genasense plus dacarbazine (DTIC) in chemotherapy-naïve subjects with advanced melanoma and low LDH. Pigment Cell Res. 2007;20:538 (Abstract T-26) |
| Contact name | Dr Claus Garbe |
| Address |
University Medical Centre
Liebermeisterstr. 25 |
| City/town | Tuebingen |
| Zip/Postcode | 72074 |
| Country | Germany |
| Tel | +49 707 1298 7110 |
| Fax | +49 707 129 5187 |
| claus.garbe@med.uni-tuebingen.de | |
| Sponsor | Genta Incorporated (USA) |
| Address |
200 Connell Drive
Berkeley Heights |
| City/town | New Jersey |
| Zip/Postcode | 07922 |
| Country | United States of America |
| Tel | +1 908 219 3113 |
| Fax | +1 908 219 3181 |
| MEDINFO@genta.com | |
| Sponsor website: | http://www.genta.com |
| Date applied | 14/04/2008 |
| Last edited | 09/06/2008 |
| Date ISRCTN assigned | 09/06/2008 |
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