Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Phase II Study of Docetaxel in Combination With Oxaliplatin With or Without 5-FU or Capecitabine in Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease
Brief Summary: This phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part I) determined the optimal dose by assessing the safety and tolerability of 2 dose levels in each arm. The optimal dose was administered in the Part II study. Participants who received the optimal dose in each treatment arm in Part I were included in the Part II analysis population.

Primary objective:

* To assess the time to progression (TTP) of Docetaxel in combination with Oxaliplatin with or without 5-Fluorouracil (5-FU) or Capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease (part II).

Secondary objectives:

* To establish the safety profile.
* To assess the Overall Response Rate (ORR) based on the World Health Organization (WHO) criteria
* To assess the Overall Survival (OS)


Options:
A: Arm Label: Olaparib+ paclitaxel; Type: EXPERIMENTAL; Interventions: Drug: Olaparib, Drug: Paclitaxel | Arm Label: Placebo+paclitaxel; Type: PLACEBO_COMPARATOR; Interventions: Drug: Paclitaxel, Drug: Placebo | Intervention Type: DRUG; Name: Olaparib; Assigned to Arm(s): Olaparib+ paclitaxel | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Olaparib+ paclitaxel, Placebo+paclitaxel | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo+paclitaxel
B: Arm Label: TE (Taxotere and Eloxatin); Type: EXPERIMENTAL; Interventions: Drug: Docetaxel + Oxaliplatin | Arm Label: TEF (Taxotere, Eloxatin and 5-FU); Type: EXPERIMENTAL; Interventions: Drug: Docetaxel + Oxaliplatin + 5-FU | Arm Label: TEX (Taxotere, Eloxatin and Xeloda); Type: EXPERIMENTAL; Interventions: Drug: Docetaxel + Oxaliplatin + Capecitabine | Intervention Type: DRUG; Name: Docetaxel + Oxaliplatin; Assigned to Arm(s): TE (Taxotere and Eloxatin) | Intervention Type: DRUG; Name: Docetaxel + Oxaliplatin + 5-FU; Assigned to Arm(s): TEF (Taxotere, Eloxatin and 5-FU) | Intervention Type: DRUG; Name: Docetaxel + Oxaliplatin + Capecitabine; Assigned to Arm(s): TEX (Taxotere, Eloxatin and Xeloda)
C: Intervention Type: DRUG; Name: continuous infusion of 5-fluorouracil; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: combination of irinotecan and cisplatin; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: oral administration of S-1; Assigned to Arm(s): N/A
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: B