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Capecitabine, Carboplatin and Weekly Paclitaxel for Patients With Solid Tumors and Adenocarcinoma of Unknown Primary
This study is currently recruiting participants.
Verified by Ohio State University Comprehensive Cancer Center, December 2007
First Received: September 12, 2005   Last Updated: December 27, 2007   History of Changes
Sponsored by: Ohio State University Comprehensive Cancer Center
Information provided by: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00201734
  Purpose

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

MedlinePlus related topics: Cancer
Drug Information available for: Paclitaxel Carboplatin Capecitabine
U.S. FDA Resources
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

Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 66
Study Start Date: June 2005
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Capecitabine
    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.
    Drug: Carboplatin
    Levels 1-5: AUC of 6 every 4 weeks.
    Drug: Paclitaxel
    Level 1-3: 60 mg/m2/week. Level 4: 80 mg/m2/week. Level 5: 100 mg/m2/week.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Phase I:

  • All advanced solid malignancies
  • Any prior chemotherapy permitted
  • Performance Status 0-2

Inclusion Criteria for Phase II:

  • Adenocarcinoma of unknown primary
  • No prior chemo permitted
  • Performance Status 0-2
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00201734

Contacts
Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com

Locations
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Tony Bekaii-Saab Ohio State University
  More Information

No publications provided

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

Study placed in the following topic categories:
Antimetabolites
Capecitabine
Neoplasms, Unknown Primary
Paclitaxel
Tubulin Modulators
Neoplasm Metastasis
Antimitotic Agents
Carboplatin
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009