Ramucirumab 8 / Paclitaxel 80, adenocarcinoma esophagogastric junction and stomach

Protocol-ID: 327 V1.2 (Short), RAMU8/PACL80, AEG/Gastric Ca

Indication(s)

Gastric Cancer; ICD-10 C16.-, C16.0
Esophageal Cancer (Adenocarcinoma Esophagogastric Junction (AEG)); ICD-10 C15.-

Protocol classification

Classification: alternative
Intensity: Standard dose
Therapy mode: Second line
Therapy intention: palliative

Cycles

Cycle length 28 days, recommended cycles: 5

Risks

Emetogenicity (MASCC/ESMO): low (10-30%)
Neutropenia: high (21-40%)
Febrile Neutropenia: low (<10%)
Thrombocytopenia below 50 000/µl: low (<10%)
Anemia Hb below 8g/dl: moderate (6-15%)
Hypertension: CTC AE °1-2: 10%; °3-4: 14%
Proteinuria: CTC AE °1-2: 15%; °3-4: 1%
Fatigue: CTC AE °1-2: 45%; °3-4: 12%
Infusion Reaction: CTC AE °1-2: 5%; °3-4: 1%
Hemorrhage: CTC AE °1-2: 38%; °3-4: 5%
Neuropathy: CTC AE °1-2: 38%; °3-4: 8%

Therapy

Day	Substance	Dosage	Appl.	Inf. time	Procedure
HYD Hydration: Balanced Crystalloid Solution
Access: peripheral venous
Hydration before, during, or after antitumor therapy
1,15	Balanced Crystalloid Solution	500 ml	i.v.	60 min	60 min before Ramucirumab (d1,15)

8	Balanced Crystalloid Solution	500 ml	i.v.	60 min	60 min before Paclitaxel (d8)

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
AP Allergy prophylaxis: Paclitaxel
Access: peripheral venous
Dexamethasone, dimetinden maleate, cimetidine
1,15	Dexamethasone	20 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Ramucirumab (d1,15)
8	Dexamethasone	20 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Paclitaxel (d8)
1,15	Dimetinden	4 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Ramucirumab (d1,15)
8	Dimetinden	4 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Paclitaxel (d8)
1,15	Cimetidine	300 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Ramucirumab (d1,15)
8	Cimetidine	300 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Paclitaxel (d8)

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
CTX Medical tumor therapy: RAMU8/PACL80
Access: peripheral venous
Ramucirumab/paclitaxel in advanced adeno-Ca of the stomach and adenco-Ca of the gastroesophageal junction.
1,15	Ramucirumab	8 mg/kg bw	NaCl 0.9% 250 ml	i.v.	60 min	Sequence
Maximum infusion rate 25 mg/min.
1,8,15	Paclitaxel	80 mg/m² BSA	NaCl 0.9% 250 ml	i.v.	60 min	Sequence

Concomitant therapy supplements

Dexamethasone for antiemesis and Ramucirumab allergy prophylaxis are covered by Paclitaxel allergy prophylaxis. For infusion reactions, see the respective summary of product characteristics.

References

Wilke H, Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial., Lancet Oncol 2014 Oct;15(11):1224-35 [PMID]

Recommendations

09/2016: European Society for Medical Oncology
06/2021: National Comprehensive Cancer Network

The publishers and authors assume no liability for the accuracy of the contents. The application is at the own responsibility of the treating physician. ©Onkopti.

Valid since: 04.07.2021