Capecitabine, Carboplatin and Weekly Paclitaxel for Patients With Solid Tumors and Adenocarcinoma of Unknown Primary

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201734
First received: September 12, 2005
Last updated: November 8, 2013
Last verified: November 2013

September 12, 2005
November 8, 2013
June 2005
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00201734 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Capecitabine, Carboplatin and Weekly Paclitaxel for Patients With Solid Tumors and Adenocarcinoma of Unknown Primary
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

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Tumors
  • Unknown Primary Tumors
  • Adenocarcinoma
  • 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.
    Other Name: Xeloda
  • Drug: Carboplatin
    Levels 1-5: AUC of 6 every 4 weeks.
    Other Names:
    • Paraplatin
    • CBDCA
  • Drug: Paclitaxel
    Level 1-3: 60 mg/m2/week. Level 4: 80 mg/m2/week. Level 5: 100 mg/m2/week.
    Other Names:
    • Onxol
    • Taxol
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.
Interventions:
  • Drug: Capecitabine
  • Drug: Carboplatin
  • Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
57
Not Provided
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00201734
OSU-0317, NCI-2011-03593
Yes
Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
Roche Pharma AG
Principal Investigator: Tony Bekaii-Saab Ohio State University
Ohio State University Comprehensive Cancer Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP