Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Rare Diseases

Neoplasm Metastasis

Stomach Neoplasms

Neoplastic Processes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Trastuzumab

Docetaxel

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Antineoplastic Agents, Immunological

Trastuzumab(8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) Capecitabine(2000mg/m2d, d1-14,every 3 weeks) Docetaxel (60mg/m2 every 3 weeks for 6 cycles).All patients will continue to receive trastuzumab and Capecitabine until either disease progression, occurrence of unacceptable toxicity or withdrawal from the study for another reason.

Trastuzumab (Herceptin) will be administered at a loading dose of 8 mg/kg (on day 1) followed by 6mg/kg i.v. infusion every 3 weeks (q3w), until disease progress or intolerable toxicity.

Docetaxel 60mg/m2 (on day 1) every 3 weeks for 6 cycles.

Capecitabine (Xeloda) 2000mg/m2d, d1-14, every 3 weeks until disease progress or intolerable toxicity.

Ruihua Xu, M.D,Ph.D

Patients with inoperable, locally advanced or recurrent and/or HER2-positive metastatic gastric or gastro-esophageal junction cancer, with no prior treatment for metastatic disease are to be recruited in the study. In the current study, the efficacy and safety of Trastuzumab in combination with Capecitabine/Docetaxel will be evaluated in Chinese patients with HER2 positive advanced or recurrent gastric cancer.60 patients could provide adequate precision rather than controlling type I\&II error. Assuming the target PFS is 6.7m, 60 patients will give 90% CI of (5.5, 8.4). Considering the 5% drop out rate, 65 patients will be enrolled.

This is a phase II, multi-center, open label, single arm, interventional study. Patients with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma who have not received prior treatment for metastatic disease will be treated with trastuzumab(8 mg/kg loading dose followed by 6 mg/kg every 3 weeks ),Capecitabine(2000mg/m2d, d1-14,every 3 weeks) and Docetaxel (60mg/m2 every 3 weeks for 6 cycles).All patients will continue to receive trastuzumab and Capecitabine until either disease progression, occurrence of unacceptable toxicity or withdrawal from the study for another reason.Primary endpoints is PFS and secondary endpoints are ORR, OS and Safety.Recruitment period:24 months;PFS follow-up period: 80% PFS events;OS follow-up period: 18 months or 80% OS events, whichever occurs first.

Trastuzumab Plus Docetaxel and Capecitabine For First Line Treatment of Her2-Positive Advanced Gastric Cancer

Phase II Study of Trastuzumab in Combination With Chemotherapy (Docetaxel Plus Capecitabine) For First Line Treatment of Her2-Positive Advanced Gastric or Gastro-Esophageal Junction Cancer

The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death,

Overall tumor response: This is defined as the occurrence of either a confirmed complete (CR) or a partial (PR) best overall response as determined by the RECIST criteria from confirmed radiographic evaluations of target and non-target lesions.

Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.

Adverse events and laboratory tests graded according to the NCI-CTC AE Version 4.

Fudan University

307 Hospital of PLA

Shandong Tumor Hospital

Tongji Hospital

West China Hospital

Shandong Provincial Hospital

Second Affiliated Hospital of Suzhou University

Tianjin Medical University General Hospital

Second Affiliated Hospital, School of Medicine, Zhejiang University

Sixth Affiliated Hospital, Sun Yat-sen University

Nanfang Hospital, Southern Medical University

Sun Yat-sen University

Vice-president and Professor

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients with metastatic colorectal cancer who achieved objective response or stable disease after 4-6 months first-line chemotherapy would stop the chemotherapy and observation.

Patients with metastatic colorectal cancer who achieved objective response or stable disease after 4-6 months first-line chemotherapy could continue to receive oral capecitabine as maintenance therapy, capecitabine, 1000mg/m2 bid d1-14, every 3 week.

The maintenance treatment was continued until progression, unacceptable toxicity, or patient withdrawal.

maintenance with apecitabine，1,000 mg/m2 twice a day， days1-15，every 3 weeks，until progression, unacceptable toxicity, or patient withdrawal.

Patients with metastatic colorectal cancer who achieved objective response or stable disease after 4-6 months first-line chemotherapy would stop the chemotherapy and observation

Observation

Colorectal cancer is one of the most common malignant tumors, with the morbidity of approximate 100 million cases per year. About 40% of patients present with metastatic (stage IV) colorectal cancer at the time of diagnosis, and about 25% of patients with local lesion will ultimately develop metastatic disease.

5-Fluorouracil（5-FU) was the only efficacious treatment for metastatic colorectal cancer before the nineties of the 20th century, and afterwards as the discovery of chemotherapy such as oxaliplatin, irinotecan and capecitabine, response rate as well as survival had been improved greatly.

Most of advanced colorectal cancer will progress after first-line treatment; therefore, seeking an efficient and low toxic maintaining regimen to prolong PFS becomes a hot topic in oncologic field. Some clinical researches demonstrated that maintaining treatment followed first-line treating advanced NSCLC could extend PFS and OS. In metastatic colorectal cancer, patients receiving 5-FU/leucovorin(LV) maintaining therapy experienced significantly longer PFS than that stopped chemotherapy after six cycles of FOLFOX4 in OPTIMOX2 study. One phase II study shown that median PFS was 13.9 months, and median OS was 31 months in 30 patients receiving first-line treatment of six- month FOLFOX4 followed by UFT as maintaining treatment . A non-randomized small sample study conducted in department of medical oncology of Sun Yat-Sen University Cancer Center indicated that patients receiving first-line treatment of XELOX followed by capecitabine as maintaining therapy has significantly prolonged median TTP, comparing with the non-maintaining treatment patients,(14months vs. 9 month, respectively).

Above all, so far, there is no data to demonstrate that regular 4-6 month chemotherapy followed by maintaining treatment could prolong TTP and OS for advanced colorectal cancer. Capecitabine is effective for colorectal cancer, and was approved as palliative treatment for advanced colorectal cancer and adjuvant chemotherapy; in addition, with its relative less frequency of side effects and convenient oral administration, capecitabine as maintaining regimen could be prone to be accepted by patients. Therefore, our study is designed to investigate that capecitabine as maintaining treatment after first-line palliative chemotherapy could improve TTP and OS for patients with advanced colorectal cancer through a perspective randomized clinical study.

Patients with metastatic colorectal cancer who achieved objective response or stable disease after 4-6 months first-line chemotherapy were randomly assigned to one of two groups, to receive either capecitabine (2000 mg/m2 per day on days 1-14,Q3W) as maintenance therapy or observation. The treatment will continue until disease progression or unacceptable toxicity.

Maintenance Treatment With Capecitabine in Colorectal Cancer Patients

Maintenance Treatment With Capecitabine Versus Observation After First Line Chemotherapy in Patients With Metastatic Colorectal Cancer: a Randomized Phase II Study

defined as the interval between initial treatment and the first documentation of disease progression or death

measured from the initiation of chemotherapy to the date of the last follow-up or death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trastuzumab Plus Docetaxel and Capecitabine For First Line Treatment of Her2-Positive Advanced Gastric Cancer	NCT02004769	Stomach Neoplas... Neoplasms Metas... ERBB2 Gene Ampl...	Trastuzumab Docetaxel Capecitabine	18 Years - 75 Years	Sun Yat-sen University
Maintenance Treatment With Capecitabine in Colorectal Cancer Patients	NCT02027363	Colorectal Neop... Neoplasms Metas...	Capecitabine Observation	18 Years - 75 Years	Sun Yat-sen University
Maintenance Treatment With Capecitabine in Colorectal Cancer Patients	NCT02027363	Colorectal Neop... Neoplasms Metas...	Capecitabine Observation	18 Years - 75 Years	Sun Yat-sen University
Maintenance Treatment With Capecitabine in Colorectal Cancer Patients	NCT02027363	Colorectal Neop... Neoplasms Metas...	Capecitabine Observation	18 Years - 75 Years	Sun Yat-sen University

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