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

Carcinoma

Adenocarcinoma

Recurrence

Rectal Neoplasms

Colonic Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antibodies

Antibodies, Monoclonal

Irinotecan

Cetuximab

Camptothecin

Immunoglobulins

Pertuzumab

Immunoglobulins, Intravenous

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Patients receive pertuzumab IV over 30-60 minutes and trastuzumab IV over 30-120 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients receive cetuximab IV over 60-120 minutes and irinotecan hydrochloride IV over 90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may optionally crossover to Arm I.

Irinotecan Hydrochloride

Laboratory Biomarker Analysis

HER-2 testing

Kanwal Raghav

This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to cetuximab and irinotecan hydrochloride in treating patients with HER2/neu amplified colorectal cancer that has spread from where it started to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab and pertuzumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cetuximab and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trastuzumab and pertuzumab may work better compared to cetuximab and irinotecan hydrochloride in treating patients with colorectal cancer.

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of trastuzumab and pertuzumab (TP) (Arm 1) in HER-2 amplified metastatic colorectal cancer (mCRC) by comparing progression-free survival (PFS) on TP compared to control arm (Arm 2) of cetuximab and irinotecan hydrochloride (irinotecan) (CETIRI).

SECONDARY OBJECTIVES:

I. To evaluate the overall response rate (ORR), including confirmed complete and partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, in treatment Arms 1 and 2.

II. To evaluate the overall survival (OS) in treatment Arms 1 and 2. III. To evaluate the safety and toxicity of TP compared to CETIRI.

TERTIARY OBJECTIVES:

I. To estimate the rates of PFS, OS, and ORR in patients who crossover to TP (Arm 3) after disease progression on CETIRI.

II. To bank images for future retrospective analysis. III. To evaluate if HER-2/centromeric probe (CEP17) signal ratio and HER-2 gene copy number (GCN) are predictive of clinical efficacy for patients receiving TP versus CETIRI.

IV. To bank tissue and blood samples for other future correlative studies from patients enrolled on the study.

OUTLINE: Patients with HER2 gene amplification are randomized to 1 of 2 arms.

ARM I: Patients receive pertuzumab intravenously (IV) over 30-60 minutes and trastuzumab IV over 30-120 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive cetuximab IV over 60-120 minutes and irinotecan hydrochloride IV over 90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may optionally crossover to Arm I.

After completion of study treatment, patients are followed up for 3 years.

S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery

S1613, A Randomized Phase II Study of Trastuzumab and Pertuzumab (TP) Compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (mCRC) With HER-2 Amplification

To evaluate the efficacy of trastuzumab and pertuzumab (TP) in HER-2 amplified metastatic colorectal cancer (mCRC) by comparing progression-free survival (PFS) on TP compared to control arm of cetuximab and irinotecan (CETIRI). Progression-free survival is defined as the time from date of randomization to date of first documentation of progression. Using RECIST 1.1, progression is defined as a 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed and an absolute increase of at least 0.5 cm, unequivocal progression of non-measurable disease in the opinion of the treating physician, appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration (defined as, global deterioration of health status requiring discontinuation of treatment without objective evidence of progression), or death due to any cause.

To evaluate the overall response rate (ORR), including confirmed complete and partial response per RECIST 1.1, in the TP and CETIRI treatment arms. Overall response rate includes complete response(CR) and partial response(PR). Complete response is defined as complete disappearance of all target and non-target lesions and no related symptoms. Partial response is defined as a greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions for patients with at least one measurable lesion.

Percentage of participants still alive 2 years after the last accrual to registration step 2. Overall survival is defined as time from date of registration to date of death due to any cause. Patients last known to be alive are censored at their last contact date.

Routine toxicities were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0, and SAEs were evaluated according to CTCAE version 5.0. Only adverse events that are possibly, probably, or definitely related to study drug are reported.

National Cancer Institute (NCI)

SWOG Cancer Research Network

CTCAE version 5.0 was used for reporting SAEs and CTCAE version 4.0 was used for routine toxicity reporting. All-Cause mortality was assessed in all analyzable participants, 26 participants in the Trastuzumab + Pertuzumab arm and 27 participants in the Cetuximab + Irinotecan arm. Due to 1 participant refusal of treatment, there were only 26 participants in the Cetuximab + Irinotecan arm that were evaluable for AEs and 26 participants in the Trastuzumab + Pertuzumab arm evaluable for AEs.

Participants receive pertuzumab intravenously (IV) over 30-60 minutes and trastuzumab IV over 30-120 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Trastuzumab + Pertuzumab

Participants receive cetuximab IV over 60-120 minutes and irinotecan hydrochloride IV over 90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Participants with documented disease progression may optionally crossover to Arm I. The number of affected participants in All-Cause Mortality includes participants that died after they crossed over to Arm I.

Cetuximab + Irinotecan

Following radiographic documentation by RECIST 1.1 of disease progression, participants initially randomized and treated with Cetuximab + Irinotecan may register to Step 3 Crossover Registration to be treated with Trastuzumab + Pertuzumab according to Arm/Group 1's description.

Crossover: Trastuz +Pertuz

Participants receive cetuximab IV over 60-120 minutes and irinotecan hydrochloride IV over 90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Participants with documented disease progression may optionally crossover to Arm I.

Total

Age, Continuous

Sex: Female, Male

Hispanic

Race/Ethnicity, Customized

Race

Number of Participants with Prior Use of Irinotecan

HER2/CEP17 Ratio

Gastrointestinal Committee Statistician

This population includes the 53 eligible and evaluable participants. 26 in the Trastuzumab + Pertuzumab arm and 27 in the Cetuximab + Irinotecan arm.

Progression-free Survival(PFS)

This population includes the 53 eligible and evaluable participants. 26 participants in the Trastuzumab + Pertuzumab arm and 27 participants in the Cetuximab + Irinotecan arm.

Overall Response Rate (ORR) for TP and CETIRI Treatment Arms

2 Year Overall Survival (OS) for TP and CETIRI Treatment Arms

Abdominal pain

Alanine aminotransferase increased

Alkaline phosphatase increased

Anemia

Anorexia

Atrial fibrillation

Diarrhea

Dyspnea

Fatigue

Gastrointestinal disorders - Other, specify

Hypokalemia

Hypomagnesemia

Infusion related reaction

Leukocytosis

Lymphocyte count decreased

Rash acneiform

Rash maculo-papular

Thromboembolic event

Vomiting

Participants who were eligible and received at least one dose of protocol treatment.

Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs.

Randomization

Crossover: Trastuzumab + Pertuzumab

Trastuzumab biosimilar HLX02

Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Gini F Fleming

Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage III, stage IV, or recurrent endometrial cancer.

PRIMARY OOBJECTIVES:

I. Determine the antitumor activity of trastuzumab (Herceptin), in terms of response, in patients with advanced, recurrent, or persistent endometrial adenocarcinoma that demonstrates HER2/neu gene amplification by fluorescent in situ hybridization.

II. Determine the toxicity of this regimen in these patients.

SECONDARY OBJECTIVES:

I. Determine the progression-free and overall survival of patients treated with this regimen.

II. Determine the effects of prognostic factors (i.e., initial performance status and histological grade) in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 25-42 patients will be accrued for this study within 12 years.

Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

A Phase II Evaluation of Trastuzumab (MoAb HER2) in Patients With Advanced, Recurrent or Persistent Endometrial Carcinoma With or Without Prior Chemotherapy

Will be evaluated with non-parametric statistics (such as the log-rank test) through comparisons with the historical controls.

Comparisons will be made through a Cox model, which allows for adjustments with the prognostic variables.

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
S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery	NCT03365882	Colon Adenocarc... ERBB2 Gene Ampl... Rectal Adenocar... Recurrent Colon... Recurrent Recta... Stage III Colon... Stage III Recta... Stage IIIA Colo... Stage IIIA Rect... Stage IIIB Colo... Stage IIIB Rect... Stage IIIC Colo... Stage IIIC Rect... Stage IV Colon ... Stage IV Rectal... Stage IVA Colon... Stage IVA Recta... Stage IVB Colon... Stage IVB Recta...	Cetuximab Irinotecan Hydr... Laboratory Biom... Pertuzumab Trastuzumab HER-2 testing	18 Years -	SWOG Cancer Research Network
Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer	NCT00006089	Endometrial Ade... ERBB2 Gene Ampl... Recurrent Uteri... Stage III Uteri... Stage IV Uterin...	Laboratory Biom... Trastuzumab	18 Years -	National Cancer Institute (NCI)
Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer	NCT00006089	Endometrial Ade... ERBB2 Gene Ampl... Recurrent Uteri... Stage III Uteri... Stage IV Uterin...	Laboratory Biom... Trastuzumab	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for erbb2 gene amplification