Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Lapatinib Versus Lapatinib With Capecitabine as Second-line Treatment in Her2-Overexpressing Metastatic Gastro-Esophageal Cancer: A Randomized Phase II Trial
Brief Summary: Combining Erb inhibitors, such lapatinib, and TS inhibitors, such as capecitabine, may be a beneficial contribution to current treatment paradigms since preclinical data suggest that lapatinib alone can decrease TS mRNA and is synergistic with capecitabine in some cell lines, which may contribute to clinical benefit. The study described in this protocol has been designed to establish the anti-tumor activity of Lapatinib with or without capecitabine in the treatment of Her2 overexpressing metastatic gastric- and gastro-esophageal cancer, and to search for molecular correlates that may be associated with response to this compound.

The majority of patients with metastatic gastric and gastro-esophageal cancer undergo first-line combined chemotherapy (e.g. platin derivates and fluoropyrimidines, sometimes combined to a taxane), but the role of second-line chemotherapy has not yet been defined. Therefore, progression during or shortly after first-line chemotherapy is a medical condition no standard medical approach exists. The overexpression of EGFR and Her2 in gastric and gastroesophageal cancer make these indications prime candidate for treatment with the dual ErbB1/2 tyrosine kinase inhibitor (TKI) Lapatinib.


Options:
A: Arm Label: Phase 2 Arm C; Type: PLACEBO_COMPARATOR; Interventions: Drug: Capecitabine, Drug: Epirubicin, Drug: Cisplatin, Drug: Placebo | Arm Label: Phase 1b; Type: OTHER; Interventions: Drug: Capecitabine, Drug: Epirubicin, Drug: AMG 102, Drug: Cisplatin | Arm Label: Phase 2 Arm B; Type: ACTIVE_COMPARATOR; Interventions: Drug: Capecitabine, Drug: Epirubicin, Drug: AMG 102, Drug: Cisplatin | Arm Label: Phase 2 Arm A; Type: ACTIVE_COMPARATOR; Interventions: Drug: Capecitabine, Drug: Epirubicin, Drug: AMG 102, Drug: Cisplatin | Intervention Type: DRUG; Name: Capecitabine; Assigned to Arm(s): Phase 1b, Phase 2 Arm A, Phase 2 Arm B, Phase 2 Arm C | Intervention Type: DRUG; Name: Epirubicin; Assigned to Arm(s): Phase 1b, Phase 2 Arm A, Phase 2 Arm B, Phase 2 Arm C | Intervention Type: DRUG; Name: AMG 102; Assigned to Arm(s): Phase 1b, Phase 2 Arm A, Phase 2 Arm B | Intervention Type: DRUG; Name: Cisplatin; Assigned to Arm(s): Phase 1b, Phase 2 Arm A, Phase 2 Arm B, Phase 2 Arm C | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Phase 2 Arm C
B: Arm Label: ECX; Type: EXPERIMENTAL; Interventions: Drug: Epirubicin, Drug: Cisplatin, capecitabine | Arm Label: CX; Type: ACTIVE_COMPARATOR; Interventions: Drug: Cisplatin, capecitabine | Intervention Type: DRUG; Name: Epirubicin; Assigned to Arm(s): ECX | Intervention Type: DRUG; Name: Cisplatin, capecitabine; Assigned to Arm(s): CX, ECX
C: Arm Label: B; Type: EXPERIMENTAL; Interventions: Drug: AMG 386 3mg/kg, Drug: Cisplatin, Drug: Capecitabine | Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: AMG 386 10mg/kg, Drug: Cisplatin, Drug: Capecitabine | Arm Label: C; Type: ACTIVE_COMPARATOR; Interventions: Drug: AMG 386 placebo, Drug: Cisplatin, Drug: Capecitabine | Intervention Type: DRUG; Name: AMG 386 placebo; Assigned to Arm(s): C | Intervention Type: DRUG; Name: AMG 386 10mg/kg; Assigned to Arm(s): A | Intervention Type: DRUG; Name: AMG 386 3mg/kg; Assigned to Arm(s): B | Intervention Type: DRUG; Name: Cisplatin; Assigned to Arm(s): C | Intervention Type: DRUG; Name: Capecitabine; Assigned to Arm(s): C | Intervention Type: DRUG; Name: Cisplatin; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Capecitabine; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Cisplatin; Assigned to Arm(s): B | Intervention Type: DRUG; Name: Capecitabine; Assigned to Arm(s): B
D: Arm Label: Arm A: Lapatinib; Type: EXPERIMENTAL; Interventions: Drug: Lapatinib | Arm Label: Arm B; Type: EXPERIMENTAL; Interventions: Drug: Lapatinib plus capecitabine | Intervention Type: DRUG; Name: Lapatinib; Assigned to Arm(s): Arm A: Lapatinib | Intervention Type: DRUG; Name: Lapatinib plus capecitabine; Assigned to Arm(s): Arm B

Answer: D