Esophageal Cancer Clinical Trial
LOGiC – Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib
Summary
This is an international multi-center trial that will enroll patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors have amplification of the ErbB2 (HER2) gene. The trial will investigate whether lapatinib, when added to the chemotherapy regimen, capecitabine plus oxaliplatin (CapeOx), extends the time to progression and overall survival. Tumor ErbB2 (HER2) status must be known before trial entry. CapeOx is administered to all patients, and patients will be randomly assigned to receive either lapatinib or placebo.
Eligibility Criteria
Inclusion Criteria:
Signed informed consent; Histologically confirmed gastric, esophageal, or gastro-esophageal junction adenocarcinoma; disease that is locally advanced (unresectable), metastatic, or locally recurrent disease; Measurable or non-measurable, but radiologically evaluable disease, according to RECIST; ErbB2 (HER2)positive; Age =18 years; ECOG Performance status = 2; Adequate organ function, including adequate hematologic, renal and liver function; Cardiac ejection fraction within institutional range of normal as measured by echocardiogram; Able to swallow and retain oral medications, and/or receive enteral medications via gastrectomy feeding tube; Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study; Prior gastric surgery is permitted if > 3 weeks prior and recovered; Prior chemotherapy for non-gastric malignancy if > than 5 years; Prior neoadjuvant and/or adjuvant chemotherapy for early stage gastric cancer if > 6 months since completion; At least 4 weeks since prior radiotherapy; Prior biologic, hormonal, or immunologic cancer treatment if > 5 years since treatment.
Exclusion Criteria:
Pregnant or lactating females; Known history of active CNS disease; Uncontrolled ascites; Concurrent anti-cancer therapy; Gastric carcinoid, epidermoid, sarcomas, or squamous cell carcinoma; Prior palliative chemotherapy for the treatment of gastric cancer; Prior treatment with oxaliplatin < 12 months; Malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease; Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure; Pre-existing grade = 2 motor or sensory neuropathy; Uncontrolled infection; Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject''s safety; Active hepatic or biliary disease; History of other malignancy except if disease-free for 5 years, a history of completely resected non-melanoma skin cancer, or a successfully treated in situ carcinoma; Unresolved or unstable serious toxicity from prior administration of another investigational drug and/or prior cancer treatment; Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent; Known history of DPD deficiency; Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib, capecitabine, fluorouracil, platins or their excipients; Use of any investigational drug within 30 days prior randomization; Use of concurrent prohibited medications that would interact with study medications
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 173 Locations for this study
Alhambra California, 91801, United States
Fullerton California, 92835, United States
La Verne California, 91750, United States
Northridge California, 91328, United States
Oxnard California, 93030, United States
Redondo Beach California, 90277, United States
Santa Maria California, 93454, United States
Santa Monica California, 90404, United States
Terre Haute Indiana, 47802, United States
Henderson Nevada, 89052, United States
Ciudad Aut6noma de Buenos Aires Buenos Aires, C1050, Argentina
Quilmes Buenos Aires, 1878, Argentina
Neuquen Neuquén, Q8300, Argentina
Cipolletti Río Negro, R8324, Argentina
Rosario Santa Fe, S2000, Argentina
Ciudad Autonoma de Buenos Aires , 1264, Argentina
La Rioja , F5300, Argentina
Santa Fe , 3000, Argentina
Tucuman , 4000, Argentina
Belo Horizonte Minas Gerais, 30110, Brazil
Belo Horizonte Minas Gerais, 30150, Brazil
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Porto Alegre Rio Grande Do Sul, 90050, Brazil
Florianopolis Santa Catarina, 88034, Brazil
Barretos São Paulo, 14784, Brazil
Jau São Paulo, 17210, Brazil
Santo Andre São Paulo, 09060, Brazil
Sao Paulo São Paulo, 01221, Brazil
Sao Paulo São Paulo, 01246, Brazil
Sao Paulo São Paulo, 01308, Brazil
Rio de Janeiro , 20230, Brazil
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Saint John New Brunswick, E2L 4, Canada
London Ontario, N6A 4, Canada
Toronto Ontario, M4C 3, Canada
Toronto Ontario, M5B 1, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2W 1, Canada
Montreal Quebec, H3G 1, Canada
Temuco Región De La Araucania, 481-0, Chile
Santiago Región Metro De Santiago, 75009, Chile
Vina del Mar Valparaíso, 254-0, Chile
Santiago , 75100, Chile
Hefei Anhui, 23002, China
Guangzhou Guangdong, 51051, China
Ha Er Bin Heilongjiang, 15004, China
Nanjing Jiangsu, 21000, China
Changchun Jilin, 13001, China
Chengdu Sichuan, 61004, China
Beijing , 10002, China
Beijing , 10007, China
Beijing , 10085, China
Fuzhou , 35002, China
Hangzhou , 31001, China
Qingdao , 26606, China
Shanghai , 20003, China
Shanghai , 20008, China
Tianjin , 30006, China
Tallinn , 13419, Estonia
Tartu , 51014, Estonia
Pokfulam , , Hong Kong
Tuen Mun , , Hong Kong
Gyor , H-902, Hungary
Kaposvar , 7400, Hungary
Kecskemet , 6000, Hungary
Miskolc , 3526, Hungary
Pecs , 7624, Hungary
Szeged , 6720, Hungary
Szolnok , 5004, Hungary
Calcutta , 70002, India
Coimbatore , 64103, India
Kochi , 68204, India
Kochi , , India
Kolkata , 700 0, India
Nagpur , 44001, India
New Delhi , , India
Parel , 40001, India
Pune , 41100, India
Trivandrum , 69501, India
Beer-Sheva , 84101, Israel
Haifa , 31096, Israel
Jerusalem , 91031, Israel
Petah-Tikva , 49100, Israel
Ramat Gan , 52621, Israel
Rehovot , 76100, Israel
Tel Aviv , 64239, Israel
Zrifin , 70300, Israel
L'Aquila Abruzzo, 67100, Italy
Rionero In Vulture (PZ) Basilicata, 85028, Italy
Cesena Emilia-Romagna, 47023, Italy
Meldola (FC) Emilia-Romagna, 47014, Italy
Modena Emilia-Romagna, 41100, Italy
Parma Emilia-Romagna, 43100, Italy
Piacenza Emilia-Romagna, 29100, Italy
Rimini Emilia-Romagna, 47900, Italy
Udine Friuli-Venezia-Giulia, 33100, Italy
Roma Lazio, 00152, Italy
Roma Lazio, 00161, Italy
Roma Lazio, 00168, Italy
Genova Liguria, 16132, Italy
Bergamo Lombardia, 24128, Italy
Treviglio (BG) Lombardia, 24047, Italy
Pesasro Marche, 61122, Italy
Bari Puglia, 70124, Italy
Firenze Toscana, 50139, Italy
Macerata , , Italy
Busan , 602-0, Korea, Republic of
Daegu , 700-7, Korea, Republic of
Hwasun , 519-8, Korea, Republic of
Seodaemun-gu, Seoul , 120-7, Korea, Republic of
Seoul , 110-7, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , 136-7, Korea, Republic of
Suwon, Kyonggi-do , 443-7, Korea, Republic of
Suwon , 442-7, Korea, Republic of
Acapulco Guerrero, 39670, Mexico
Mexico City , CP 14, Mexico
Oaxaca , 68000, Mexico
Amsterdam , 1105 , Netherlands
Leeuwarden , 8934 , Netherlands
Nijmegen , 6525 , Netherlands
Callao , Calla, Peru
Lima , Lima , Peru
Lima , Lima , Peru
Gdansk , 80-21, Poland
Krakow , 31-50, Poland
Olsztyn , 10-22, Poland
Olsztyn , 10-51, Poland
Plock , 09-40, Poland
Poznan , 61-86, Poland
Rybnik , 44-20, Poland
Slupsk , 76-20, Poland
Szczecin , 70-11, Poland
Torun , 87-10, Poland
Warszawa , 02-50, Poland
Warszawa , 02-78, Poland
San Juan , 00910, Puerto Rico
Chelyabinsk , 45408, Russian Federation
Kirov , 61002, Russian Federation
Kursk , 30503, Russian Federation
Moscow , 11547, Russian Federation
Omsk , 64401, Russian Federation
Ryazan , 39001, Russian Federation
Saratov , 41000, Russian Federation
Sochi , 35405, Russian Federation
St. Petersburg , 19775, Russian Federation
St. Petersburg , 19825, Russian Federation
Stavropol , 35504, Russian Federation
Ufa, , 45005, Russian Federation
Tainan , 704, Taiwan
Taipei , 104, Taiwan
Taipei , 112, Taiwan
Taoyuan County , 333, Taiwan
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Hatyai, Songkhla , 90110, Thailand
Ankara , 06500, Turkey
Gaziantep , 27310, Turkey
Trabzon , 61187, Turkey
Cherkasy , 18009, Ukraine
Chernivtsi , 58013, Ukraine
Dnepropetrovsk , 49102, Ukraine
Dnipropetrovsk , 49100, Ukraine
Donetsk , 83092, Ukraine
Ivano-Frankivsk , 76018, Ukraine
Kharkiv , 61070, Ukraine
Kryvyi Rih , 50048, Ukraine
Kyiv , 03022, Ukraine
Kyiv , 03115, Ukraine
Kyiv , 04107, Ukraine
Lutsk, , 43018, Ukraine
Lviv , 79031, Ukraine
Odessa , 65055, Ukraine
Plyuty , 08720, Ukraine
Simferopil , 95023, Ukraine
Simferopol , 95023, Ukraine
Sumy , 40005, Ukraine
Ternopil , 46023, Ukraine
Uzhgorod , 88000, Ukraine
Vinnitsia , 21029, Ukraine
Zaporizhzhia , 69040, Ukraine
How clear is this clinincal trial information?