Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
Summary
Chemotherapy given together is a standard way to treat your cancer. One standard treatment includes a combination of docetaxel, cisplatin, and fluorouracil. However, the original combination of these three drugs can cause many side effects. This study is being done to find out if these three drugs can be given at lower doses more often, with fewer side effects and still maintain the same benefit as the standard way of giving this three drug combination. If your tumor overexpresses a protein called Her2, you are also eligible to receive trastuzumab with chemotherapy. Trastuzumab is a medicine that has been approved by the US Food and Drug Administration for the treatment of Her2 positive breast cancer. Trastuzumab is now also a standard treatment in combination with chemotherapy for the treatment of Her2 positive stomach cancer. If your tumor is Her2 positive, you would receive the modified administration schedule of docetaxel, cisplatin, and fluorouracil with trastuzumab.
Timeline
- Start
- 2006-10-23
- Primary completion
- 2018-10-26
- Completion
- 2018-10-26
Publications
- Mondaca S, Margolis M, Sanchez-Vega F, Jonsson P, Riches JC, Ku GY, Hechtman JF, Tuvy Y, Berger MF, Shah MA, Kelsen DP, Ilson DH, Yu K, Goldberg Z, Epstein AS, Desai A, Chung V, Chou JF, Capanu M, Solit DB, Schultz N, Janjigian YY. Phase II study of trastuzumab with modified docetaxel, cisplatin, and 5 fluorouracil in metastatic HER2-positive gastric cancer. Gastric Cancer. 2019 Mar;22(2):355-362. doi: 10.1007/s10120-018-0861-7. Epub 2018 Aug 7.
- Shah MA, Janjigian YY, Stoller R, Shibata S, Kemeny M, Krishnamurthi S, Su YB, Ocean A, Capanu M, Mehrotra B, Ritch P, Henderson C, Kelsen DP. Randomized Multicenter Phase II Study of Modified Docetaxel, Cisplatin, and Fluorouracil (DCF) Versus DCF Plus Growth Factor Support in Patients With Metastatic Gastric Adenocarcinoma: A Study of the US Gastric Cancer Consortium. J Clin Oncol. 2015 Nov 20;33(33):3874-9. doi: 10.1200/JCO.2015.60.7465.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cisplatin | Other / unclassified | 40 mg/m2 | Intravenous |
| Comparator | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 40 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Comparator | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | 4 mg/kg | — |
| Comparator | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 750 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 1000 mg/m2 | Intravenous |
| Comparator | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |
| Comparator | filgrastim | Protein / enzyme biologic | 300 ug | Subcutaneous |
| Comparator | filgrastim | Protein / enzyme biologic | 480 ug | Subcutaneous |