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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 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Tumors, Unknown Primary Tumors, Adenocarcinoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: To Determine the maximum tolerated dose

Outcome Time Frame:

Every 3 weeks

Safety Issue:

Yes

Principal Investigator

Tony Bekaii-Saab

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-0317

NCT ID:

NCT00201734

Start Date:

June 2005

Completion Date:

Related Keywords:

  • Tumors
  • Unknown Primary Tumors
  • Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms, Unknown Primary

Name

Location

Ohio State UniversityColumbus, Ohio  43210