Use of trastuzumab combination chemotherapy in patients with relapsed or metastatic gastric cancer with expression HER2 negative in the tumor tissue but positive in CTC.

Gastric Cancer Stage IV

The first-line standard treatment for gastric cancer is based on fluoropyrimidine and platinum-containing chemotherapy (FOLFOX). When the tumor expresses HER2 3+ on IHC or 2+ and is confirmed by FISH, trastuzumab at the standard dose of 8 mg / kg in D1 of the first cycle is added, followed by 6 mg / kg every 2 weeks for the remaining cycles until disease progression, unacceptable toxicity. (3) We will use the same doses of trastuzumab, but HER2 positivity is determined by immunocytochemical expression and FISH in CTCs for patients with negative expression in tissue biopsy.

Trastuzumab

AC Camargo Cancer Center

Trastuzumab to Patients With Advanced Gastric Cancer With HER2 Positive Expression in CTC

Efficacy of Adding Trastuzumab to Standard Chemotherapy in Patients With Advanced HER2-negative Gastric Cancer and HER2 Positive Expression in Circulating Tumor Cells

RECIST1.1 radiological response rate following standard treatment with combined chemotherapy with trastuzumab in relapsed or metastatic gastric cancer with positive expression of HER2 in CTC and negative in tumor tissue.

Frequency of HER2 expression among circulating tumor cells of patients with relapsed or metastatic gastric cancer with negative expression of HER2 in tumor tissue

Rachel Riechelmann

Head of Clinical Oncology Department

This is a single-phase prospective unicentric phase II study evaluating HER2 expression in circulating tumor cells and their response to standard treatment with trastuzumab combination chemotherapy in cases of positive expression in patients with relapsed or metastatic gastric cancer with expression HER2 negative in the tumor tissue.

Patients with HER2+ metastatic or unresectable adenocarcinoma of the esophagus, gastroesophageal junction or stomach will receive trastuzumab and mFOLFOX-6 in combination with KD019 to evaluate the safety, toxicity and MTD of this regimen. There will be four dose cohorts for KD019. KD019 will be administered orally continuously daily on a 28 day cycle. Trastuzumab and mFOLFOX-6 will be administered as infusions every 2 weeks at standard doses without escalation. The sequence on the days when all agents are administered will be KD019 followed by trastuzumab and mFOLFOX-6.

Esophageal Cancer

Stomach Cancer

KD019

NYU Langone Medical Center

KD019 and Trastuzumab in Patients With Esophagus, Gastroesophageal Junction and Stomach Cancer

A Phase Ib Study of KD019 Plus Trastuzumab in Patients With HER2 Overexpressed or Amplified Metastatic or Unresectable Adenocarcinoma of Esophagus, Gastroesophageal Junction and Stomach

To determine maximum tolerated dose (MTD) and RP2D of KD019 in combination with trastuzumab and mFOLFOX-6 when given to patients with HER2+ metastatic or unresectable adenocarcinoma of the esophagus, GEJ or stomach (gastric).

Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Tumor assessments will be performed using RECIST criteria (Version 1.1). Imaging scans may be done within 4 weeks prior to the first dose of study drug (baseline) and then every 12 weeks (±7 days) after the first dose of study drug until documented progression. Responses will be confirmed by repeat assessments between 28 and 35 days after the response criteria are first met.

Overall response rates are defined as partial response plus complete response. Tumor response will be based on Response evaluation Criteria in Solid Tumors (RECIST 1.1). Response rates will be estimated with exact 95% confidence intervals for each dose level. Kaplan Meier curves will be used to summarize progression free survival.

The duration of overall response is measured from the time measurement are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Tumor response will be based on Response evaluation Criteria in Solid Tumors (RECIST 1.1).

Clinical benefit rate is defined as complete response plus partial response plus stable disease >16 weeks, and will be summarized descriptively. Tumor response will be based on Response evaluation Criteria in Solid Tumors (RECIST 1.1).

Patients will undergo pharmacokinetics at the following time points:
Pre- 15 minutes pre-dosing: C1 D1, C1 D15 and then D1 only starting cycle 2 and thereafter Up to and including the cycle 6 visit.
Post- at 1 hour, 2 hours, and 4-6 hours post dosing: C1 D1, C1 D15 and 4-6 hours post dosing only on D1 only starting cycle 2 .
A PK sample will also be drawn if QTc(f) interval increases to an absolute value of >500 msec. The concentration of KD019 in these samples will be used to confirm exposure to KD019 and to further characterize the plasma PK of KD019 in this subject population.
30 days post treatment visit.

NYU Langone Health

Imatinib mesylate 300mg/day(maximum dose will be 800 mg) on day -4, -3, -2, -1, 1, 2, 3 through d21 in combination with capecitabine 1250 mg/m2 twice daily (d1-d14) and iv cisplatin 60mg/m2

Gastric Cancer

capecitabine

cisplatin

imatinib mesylate

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Imatinib, Capecitabine, and Cisplatin in Treating Patients With Unresectable or Metastatic Stomach Cancer

A Phase I Study of Capecitabine, Cisplatin and Imatinib in Patients With Unresectable or Metastatic Gastric Cancer.

Technische Universität München

Oesophagogastric Cancer

7.5mg/kg IV Day 1 of each 21 cycle of chemotherapy (6 cycles) plus day 1 of each maintenance dose every 21 days for 6 doses.

bevacizumab

dose banded as based on patient BSA. Oral dose given twice a day during each 21 day cycle of chemotherapy (6 cycles in total)

60mg/m2 IV day one of each 21 day cycle of chemotherapy (6 cycles in total)

50mg/m2 IV day one of each 21 day cycle of chemotherapy (6 cycles in total)

Epirubicin

3 cycles of ECX chemotherapy post operatively

adjuvant therapy

Surgery undertaken after 3 cycles of pre-operative chemotherapy. Followed by 3 cycles of chemotherapy.

conventional surgery

3 cycles of pre-operative ECX chemotherapy.

neoadjuvant therapy

1250mg/day Day 1-21 of each cycle of chemotherapy (6 cycles) plus day 1-21 of each maintenance course every 21 days for 6 doses.

Lapatinib

Medical Research Council ST03 Clinical Trial Page

Royal Bournemouth Hospital

Bradford Royal Infirmary

Bristol Haematology and Oncology Centre

Addenbrooke's Hospital

Cumberland Infirmary

Doncaster Royal Infirmary

St. Luke's Cancer Centre at Royal Surrey County Hospital

Huddersfield Royal Infirmary

Leeds Cancer Centre at St. James's University Hospital

Lincoln County Hospital

Aintree University Hospital

Saint Bartholomew's Hospital

St. George's Hospital

St. Mary's Hospital

Mid Kent Oncology Centre at Maidstone Hospital

Christie Hospital

Clatterbridge Centre for Oncology

Northern Centre for Cancer Treatment at Newcastle General Hospital

Derriford Hospital

Dorset Cancer Centre

Berkshire Cancer Centre at Royal Berkshire Hospital

Rochdale Infirmary

Salisbury District Hospital

Wexham Park Hospital

Southampton General Hospital

Royal Marsden - Surrey

Aberdeen Royal Infirmary

Velindre Cancer Center at Velindre Hospital

Basingstoke and North Hampshire Hospital

Birmingham Heartlands Hospital

Castle Hill Hospital

University Hospitals Coventry and Warwickshire

Beatson West of Scotland Cancer Centre

St James Hospital

Leicester Royal Infirmary

Norfolk and Norwich University Hospital

Churchill Hospital

Queens Hospital

Weston Park

Great Western Hospital

Musgrove Park Hospital

Chemotherapy With or Without Bevacizumab or Lapatinib to Treat Operable Oesophagogastric Cancer

A Randomised Phase II/III Trial of Peri-Operative Chemotherapy With or Without Bevacizumab in Operable Oesophagogastric Adenocarcinoma and A Feasibility Study Evaluating Lapatinib in HER-2 Positive Oesophagogastric Adenocarcinomas and (in Selected Centres) MRI and PET/CT Sub-studies

stomach neoplasms/tyrosine

Trastuzumab to Patients With Advanced Gastric Cancer With HER2 Positive Expression in CTC

KD019 and Trastuzumab in Patients With Esophagus, Gastroesophageal Junction and Stomach Cancer

Imatinib, Capecitabine, and Cisplatin in Treating Patients With Unresectable or Metastatic Stomach Cancer

Chemotherapy With or Without Bevacizumab or Lapatinib to Treat Operable Oesophagogastric Cancer

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