Study on Neoadjuvant Chemotherapy for Advanced Gastric Cancer

Advanced Gastric Carcinoma Clinical Trial

Official title:

Phase II Study of Paclitaxel Liposome Plus S-1 as Neoadjuvant Chemotherapy for Advanced Gastric Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02163291
• Other study ID #: LPS-01-2013
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 7, 2014
• Last updated: June 11, 2014
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: June 2014
• Source: Peking University
• Contact: Jiafu Ji, M.D.
• Email: jiafuj[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Gastric cancer is the second cause of cancer related death and China has the most gastric cancer patients in the world. Although systemic strategies, including adjuvant chemotherapy, postoperative chemoradiotherapy, perioperative chemotherapy, have evolved and showed benefits these years, the prognosis of advanced gastric cancer is still not satisfactory. Optimal regimens and optimal method administration is still being found. Neoadjuvant chemotherapy has many advantages, including downstaging the tumor, increasing R0 rate, early eradicating of micrometastasis. In previous trials, combination of paclitaxel and s-1 has showed safety and tolerance in recurrent or metastatic gastric cancer. Using liposome as a carrier, paclitaxel has a better histocompatibility and cellular affinity, resulting a improved stability and reduced toxicity. In this phase II trial, we are going to study the safety and feasibility of paclitaxel liposome plus s-1 as neoadjuvant chemotherapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed gastric cancer

• Disease at clinical stage of resectable or potentially resectable(T3-4, N0-3, M0) by CT and endoscopic ultrasonography (EUS)

• Karnofsky performance status(KPS) = 70

• No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy

• Life expectancy more than 3 months

• Adequate organ function as defined below:White Blood Cell Count (WBC) = 3.0*10^9/l, Absolute Neutrophil Count (ANC) = 1.5*10^9/l, Hemoglobin = 100 g/l, Platelets = 100*10^9/l, Total Bilirubin (TBIL) = 1.5mg/dl, Aspartate Aminotransferase(AST) and Alanine Aminotransferase(ALT) = 2.5×ULN, Alkaline pPosphatase( ALP) = 2.5×ULN, Renal Serum Creatinine < 1.5mg/dl

• Adequate lung and heart function

Exclusion Criteria:

• = grade 2 neuropathy

• History of malignancy

• With uncontrolled central nervous system metastasis

• Concurrent disease or condition that would interfere with the subject's safety (including current active hepatic, biliary, renal, respiratory disease, acute infection, severe malnutrition, uncontrolled diabetes hypertension et al)

• Severely inadequate intake of water or diet

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Gastric Carcinoma
• Stomach Neoplasms

Intervention

Drug:
• paclitaxel liposome
S-1 40 mg/m2 bid d1-14 po and paclitaxel liposome 175mg/m2 d1 intravenously infusion for 3 hours, every 3 weeks. After 2 cycles' treatment, if clinical response is complete response(CR),partial regression(PR) or stable disease(SD), another 2 cycles is administered and operation is performed after the total 4 cycles. If response is progressive disease(PD), chemotherapy is stopped and operation is performed.

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Haidian District, Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

References & Publications (7)

Chen L, Chen Q, Zhuang Z, Zhang Y, Tao J, Shen L, Shen X, Chen Z, Wang J, Zhu M, Wang H. Effect of the weekly administration of liposome-Paclitaxel combined with s-1 on advanced gastric cancer. Jpn J Clin Oncol. 2014 Mar;44(3):208-13. doi: 10.1093/jjco/hyt212. Epub 2014 Jan 22. — View Citation

Huang D, Ba Y, Xiong J, Xu N, Yan Z, Zhuang Z, Yu Z, Wan H, Zhang Y, Deng T, Zheng R, Guo Z, Hu C, Wang M, Yu Z, Yao Y, Meng J. A multicentre randomised trial comparing weekly paclitaxel + S-1 with weekly paclitaxel + 5-fluorouracil for patients with advanced gastric cancer. Eur J Cancer. 2013 Sep;49(14):2995-3002. doi: 10.1016/j.ejca.2013.05.021. Epub 2013 Jun 27. — View Citation

Lee JJ, Kim SY, Chung HC, Lee KH, Song HS, Kang WK, Hong YS, Choi IS, Lee YY, Woo IS, Choi JH. A multi-center phase II study of S-1 plus paclitaxel as first-line therapy for patients with advanced or recurrent unresectable gastric cancer. Cancer Chemother Pharmacol. 2009 May;63(6):1083-90. doi: 10.1007/s00280-008-0818-3. Epub 2008 Sep 24. — View Citation

Mochiki E, Ogata K, Ohno T, Toyomasu Y, Haga N, Fukai Y, Aihara R, Ando H, Uchida N, Asao T, Kuwano H; North Kanto Gastric Cancer Study Group. Phase II multi-institutional prospective randomised trial comparing S-1+paclitaxel with S-1+cisplatin in patients with unresectable and/or recurrent advanced gastric cancer. Br J Cancer. 2012 Jun 26;107(1):31-6. doi: 10.1038/bjc.2012.222. Epub 2012 May 22. — View Citation

Nakajo A, Hokita S, Ishigami S, Miyazono F, Etoh T, Hamanoue M, Maenohara S, Iwashita T, Komatsu H, Satoh K, Aridome K, Morita S, Natsugoe S, Takiuchi H, Nakano S, Maehara Y, Sakamoto J, Aikou T; Kyushu Taxol TS-1 Study Group. A multicenter phase II study of biweekly paclitaxel and S-1 combination chemotherapy for unresectable or recurrent gastric cancer. Cancer Chemother Pharmacol. 2008 Nov;62(6):1103-9. doi: 10.1007/s00280-008-0693-y. Epub 2008 Mar 4. — View Citation

Wang X, Zhou J, Wang Y, Zhu Z, Lu Y, Wei Y, Chen L. A phase I clinical and pharmacokinetic study of paclitaxel liposome infused in non-small cell lung cancer patients with malignant pleural effusions. Eur J Cancer. 2010 May;46(8):1474-80. doi: 10.1016/j.ejca.2010.02.002. Epub 2010 Mar 6. — View Citation

Zhang Q, Huang XE, Gao LL. A clinical study on the premedication of paclitaxel liposome in the treatment of solid tumors. Biomed Pharmacother. 2009 Sep;63(8):603-7. doi: 10.1016/j.biopha.2008.10.001. Epub 2008 Oct 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response rate	Pathology is usually reported 1 week after operation.The result of Pathological complete response rate will be accessed after all of the 30 participants operated.	up to 24 weeks	No
Secondary	Object Response Rate	Object Response Rate(ORR) is defined as the percentage of CR and PR among all of the participants under best overall outcome evaluation .Pathology is usually reported 1 week after operation.The result of Object Response Rate will be accessed after all of the 30 participants operated.	up to 24 weeks	No
Secondary	Disease Control Rate	Disease Control Rate(DC R) is defined as the percentage of CR+PR+SD among all of the participants under best overall outcome evaluation .Pathology is usually reported 1 week after operation.The result of Disease Control Rate will be accessed after all of the 30 participants operated.	up to 24 weeks	No
Secondary	Number of Participants with Adverse Eventss a Measure of Safety and Tolerability	Participants will be followed during all the s a Measure of Safety and Tolerability4 circles of chemotherapy ,an expected average of 12 weeks.Number of participants with Adverse Events will calculated as a Measure of Safety and Tolerability.	up to 12 weeks	No
Secondary	R0 rate, surgical morbidity and mortality	The results of R0 rate, surgical morbidity and mortality will be accessed after operation ,participants will be followed for the duration of hospital stay, an expected average of 2 weeks .	2 weeks	No

External Links

•   Liposome-paclitaxel has been successfully studied and approved by the State Food and Drug Administration of China.