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: 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)
B: Arm Label: Arm A (ECF + cetuximab); Type: EXPERIMENTAL; Interventions: Biological: cetuximab, Drug: ECF | Arm Label: Arm B (IC + cetuximab); Type: EXPERIMENTAL; Interventions: Biological: cetuximab, Drug: IC | Arm Label: ARM C (FOLFOX + cetuximab); Type: EXPERIMENTAL; Interventions: Biological: cetuximab, Drug: FOLFOX | Intervention Type: BIOLOGICAL; Name: cetuximab; Assigned to Arm(s): ARM C (FOLFOX + cetuximab), Arm A (ECF + cetuximab), Arm B (IC + cetuximab) | Intervention Type: DRUG; Name: ECF; Assigned to Arm(s): Arm A (ECF + cetuximab) | Intervention Type: DRUG; Name: IC; Assigned to Arm(s): Arm B (IC + cetuximab) | Intervention Type: DRUG; Name: FOLFOX; Assigned to Arm(s): ARM C (FOLFOX + cetuximab)
C: Arm Label: MLN0128P 30 mg QW; Type: EXPERIMENTAL; Interventions: Drug: MLN0128, Drug: paclitaxel | Arm Label: MLN0128P 40 mg QW; Type: EXPERIMENTAL; Interventions: Drug: MLN0128, Drug: paclitaxel | Arm Label: MLN0128P 6 mg QD×3d QW; Type: EXPERIMENTAL; Interventions: Drug: MLN0128, Drug: paclitaxel | Arm Label: MLN0128P 7 mg QD×3d QW; Type: EXPERIMENTAL; Interventions: Drug: MLN0128, Drug: paclitaxel | Arm Label: MLN0128P 8 mg QD×3d QW; Type: EXPERIMENTAL; Interventions: Drug: MLN0128, Drug: paclitaxel | Arm Label: MLN0128P 9 mg QD×3d QW; Type: EXPERIMENTAL; Interventions: Drug: MLN0128, Drug: paclitaxel | Arm Label: MLN0128P 10 mg QD×3d QW; Type: EXPERIMENTAL; Interventions: Drug: MLN0128, Drug: paclitaxel | Arm Label: MLN0128P 7 mg QD×5d QW; Type: EXPERIMENTAL; Interventions: Drug: MLN0128, Drug: paclitaxel | Arm Label: MLN0128P 8 mg QD×3d QW HER2-; Type: EXPERIMENTAL; Interventions: Drug: MLN0128, Drug: paclitaxel | Arm Label: MLN0128PH 8 mg QD×3d QW HER2+; Type: EXPERIMENTAL; Interventions: Drug: MLN0128, Drug: paclitaxel, Drug: trastuzumab | Intervention Type: DRUG; Name: MLN0128; Assigned to Arm(s): MLN0128P 10 mg QD×3d QW, MLN0128P 30 mg QW, MLN0128P 40 mg QW, MLN0128P 6 mg QD×3d QW, MLN0128P 7 mg QD×3d QW, MLN0128P 7 mg QD×5d QW, MLN0128P 8 mg QD×3d QW, MLN0128P 8 mg QD×3d QW HER2-, MLN0128P 9 mg QD×3d QW, MLN0128PH 8 mg QD×3d QW HER2+ | Intervention Type: DRUG; Name: paclitaxel; Assigned to Arm(s): MLN0128P 10 mg QD×3d QW, MLN0128P 30 mg QW, MLN0128P 40 mg QW, MLN0128P 6 mg QD×3d QW, MLN0128P 7 mg QD×3d QW, MLN0128P 7 mg QD×5d QW, MLN0128P 8 mg QD×3d QW, MLN0128P 8 mg QD×3d QW HER2-, MLN0128P 9 mg QD×3d QW, MLN0128PH 8 mg QD×3d QW HER2+ | Intervention Type: DRUG; Name: trastuzumab; Assigned to Arm(s): MLN0128PH 8 mg QD×3d QW HER2+
D: Arm Label: EOX; Type: ACTIVE_COMPARATOR; Interventions: Other: EOX | Arm Label: mDCF; Type: ACTIVE_COMPARATOR; Interventions: Other: mDCF | Intervention Type: OTHER; Name: EOX; Assigned to Arm(s): EOX | Intervention Type: OTHER; Name: mDCF; Assigned to Arm(s): mDCF

Answer: A