A Randomized Phase II Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) Treatment versus Conventional DCF with Growth Factor Support in Patients with Unresectable or Metastatic Gastric and Gastroesophageal Junction Cancer

Protocol
06-103
Full Title
Phase II Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF)in Patients with Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
Phase
II
Purpose

The standard treatment for advanced gastric or gastroesophageal cancer that has spread or cannot be surgically removed is a combination of the anticancer drugs docetaxel, cisplatin, and fluorouracil. However, the original combination of these three drugs can cause many side effects.

In this study, researchers want to see if this drug combination can be given more safely and just as effectively by either lowering the doses used or by giving the drugs with a medicine that boosts white blood cell counts during treatment. Participants will therefore be randomly assigned to receive either the original schedule of docetaxel, cisplatin, and fluorouracil with the addition of a medicine to boost the immune system, or lower and more frequent doses of docetaxel, cisplatin, and fluorouracil.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of stomach, esophageal, or gastroesophageal cancer that cannot be surgically removed or has spread (metastasized). Patients may not have received chemotherapy for advanced disease.
  • Patients may not have previously received cisplatin or docetaxel.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Yelena Janjigian at 646-888-4186.

Disease(s)
Upper Gastrointestinal: Gastric Cancer