Capecitabine, Carboplatin and Weekly Paclitaxel for Patients With Solid Tumors and Adenocarcinoma of Unknown Primary
This study will determine the maximum tolerated dose of the triplet combination of capecitabine that can be administered in combination with weekly paclitaxel and every four weeks with carboplatin.
Unknown Primary Tumors
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Dose Escalation Study of Capecitabine, Carboplatin and Weekly Paclitaxel and a Phase II Trial of the Same Combination in Patients With Adenocarcinoma of Unknown Primary|
- Phase I: To Determine the maximum tolerated dose [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ]
- Phase II: Determine the objective response rate [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]
- Phase I: To determine side effects [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
- Phase II: Progression-Free Survival [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Phase II: Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Phase II: Time to Tumor Progression [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive paclitaxel IV over 60 minutes on days 1, 8, and 15, carboplatin IV over 1-2 hours on day 1, and capecitabine PO BID on days 8-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Level 1: 500 mg/m2 orally twice daily Days 8 - 21 of each cycle. Level 2: 750 mg/m2 orally twice daily Days 8 - 21 of each cycle. Level 3 - 5: 1000mg/m2 orally twice daily Days 8 - 21 of each cycle.
Other Name: XelodaDrug: Carboplatin
Levels 1-5: AUC of 6 every 4 weeks.
Other Names:Drug: Paclitaxel
Level 1-3: 60 mg/m2/week. Level 4: 80 mg/m2/week. Level 5: 100 mg/m2/week.
Rationale: The combination of the chemotherapy drugs paclitaxel and carboplatin is one of the most common combination regimens used in clinical practice for cancer. These agents are used for a variety of cancers. The current study builds on previous research about treatment schedules for administering these agents to reduce toxicity and optimize efficacy. The phase I and II portions of the current study combine paclitaxel and carboplatin with capecitabine in patients. Researchers are seeking to identify the highest dose of capecitabine and paclitaxel in combination with carboplatin for this patient population, as well as to gather information about preliminary efficacy.
Purpose: The phase I portion of this study will evaluate the maximum tolerated dose of capecitabine and paclitaxel in combination with carboplatin for patients. The phase II portion of this study will assess the objective response rate in patients using the same treatment combination. Toxicities will be closely measured in both phases of the study.
Treatment: Patients in this study will be given capecitabine, carboplatin, and paclitaxel. Capecitabine will be given through oral pills. Carboplatin and paclitaxel will be given through intravenous infusions. Treatment drugs will be given on a four-week cycle. Carboplatin will be administered on day 1, paclitaxel weekly for the first 3 weeks, and capecitabine twice daily on days 8 through 21 of each cycle. No treatments will be given during the fourth week of each treatment cycle. During the phase I portion of the study, patients may receive different doses of capecitabine and paclitaxel since the purpose is to identify the maximum tolerated dose of each drug in combination with carboplatin. Once the maximum tolerated dose of these agents is identified during phase I, the phase II portion of the study will begin. Treatments will be discontinued due to disease growth or unacceptable side effects. Several tests and exams will be given throughout the study to closely monitor patients.
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Tony Bekaii-Saab||Ohio State University|