Primary Outcome Measures:
- Maximum tolerated dose [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Toxicity [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
- Therapeutic response [ Time Frame: Prior to cycle 3 and then every 2 cycles thereafter ] [ Designated as safety issue: No ]
Intervention Details:
Drug: Capecitabine
Dose levels -2 - 1: 500 mg/m2/12 hours orally on days 8-21. Dose levels 2 - 3: 625 mg/m2/12 hours orally on days 8-21.
Drug: Docetaxel
Dose level -2: 24 mg/m2 IV on days 1 and 8. Dose levels -1 - 2: 30 mg/m2 IV on days 1 and 8. Dose level 3: 36 mg/m2 IV on days 1 and 8.
Drug: Gemcitabine
Dose levels -2 - -1: 600 mg/m2 IV over 60 minutes on days 8 and 15. Dose levels 1 - 3: 750 mg/m2 IV over 75 minutes on days 8 and 15.
Rationale: Single agent gemcitabine is considered standard care for patients with advanced pancreatic cancer. However, better treatments offering improved outcomes are needed for people with this disease. The combination of docetaxel and capecitabine has shown significant and broad clinical activity in a variety of tumors. Laboratory research on the combination of capecitabine, docetaxel, and gemcitabine indicates synergistic action against tumor cells. The current study will test this combination in patients. The drug administration schedule in this study is aimed at maximizing the potential of activation of capecitabine by both docetaxel and gemcitabine.
Treatment: Study participants will be given docetaxel, gemcitabine, and capecitabine. All study drugs will be administered through intravenous infusions in three week cycles. Docetaxel will be given on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. This schedule will be followed by 1 week of rest without administration of study drugs. Since the primary goal of this study is to identify the maximum tolerated dose of the study drugs in combination, patients who enroll in the beginning of the study will receive lower amounts of the study drugs compared to patients who enroll later in the study. Several tests and exams will be given throughout the study to closely monitor patients.
Purpose
