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Sponsored by: |
Ohio State University Comprehensive Cancer Center |
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Information provided by: | Ohio State University Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00201734 |
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.
Condition | Intervention | Phase |
---|---|---|
Tumors Unknown Primary Tumors Adenocarcinoma |
Drug: Capecitabine Drug: Carboplatin Drug: Paclitaxel |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 66 |
Study Start Date: | June 2005 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for Phase I:
Inclusion Criteria for Phase II:
Contact: Ohio State University Cancer Clinical Trial Matching Service | 866-627-7616 | osu@emergingmed.com |
United States, Ohio | |
Ohio State University | Recruiting |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Tony Bekaii-Saab | Ohio State University |
Responsible Party: | Ohio State University Comprehensive Cancer Center ( Tony Bekaii-Saab, M.D. ) |
Study ID Numbers: | OSU-0317 |
Study First Received: | September 12, 2005 |
Last Updated: | December 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00201734 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Capecitabine Neoplasms, Unknown Primary Paclitaxel Tubulin Modulators Neoplasm Metastasis |
Antimitotic Agents Carboplatin Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Neoplasms, Unknown Primary Capecitabine Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Antimitotic Agents Carboplatin Pharmacologic Actions |
Carcinoma Neoplasms Neoplastic Processes Pathologic Processes Paclitaxel Therapeutic Uses Tubulin Modulators Neoplasm Metastasis Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |