NCT00201734

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
3 years until next milestone

Results Posted

Study results publicly available

June 1, 2016

Completed
Last Updated

September 23, 2016

Status Verified

August 1, 2016

Enrollment Period

2.4 years

First QC Date

September 12, 2005

Results QC Date

April 25, 2016

Last Update Submit

August 15, 2016

Conditions

TumorsUnknown Primary TumorsAdenocarcinoma

Keywords

Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

  • Maximum Tolerated Dose in Phase I Portion of Study

    Determine the maximum tolerated dose of the triplet combination of capecitabine that can be administered in combination with weekly paclitaxel and every four weeks carboplatin.

    Every 3 weeks, for up to 24 weeks

  • Objective Response Rate (ORR) for the Phase II Portion of the Study. CR+PR Per RECIST v1.0 Criteria Using a Single Arm , Two Stage Minimax Design.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

    Every 3 weeks, for up to 24 weeks

Secondary Outcomes (4)

  • Phase I: To Determine Side Effects

    Every 3 weeks, for up to 24 weeks

  • Progression-Free Survival at 6 Months for Patients

    up to 6 years

  • One Year Survival for Patients

    Up to 1 year

  • Time to Tumor Progression for Patients

    Up to 6 years

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Drug: CapecitabineDrug: CarboplatinDrug: Paclitaxel

Interventions

CapecitabineDRUG

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.

Also known as: Xeloda
Arm I
CarboplatinDRUG

Levels 1-5: AUC of 6 every 4 weeks.

Also known as: Paraplatin, CBDCA
Arm I
PaclitaxelDRUG

Level 1-3: 60 mg/m2/week. Level 4: 80 mg/m2/week. Level 5: 100 mg/m2/week.

Also known as: Onxol, Taxol
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All advanced solid malignancies
  • Any prior chemotherapy permitted
  • Performance Status 0-2
  • Adenocarcinoma of unknown primary
  • No prior chemo permitted
  • Performance Status 0-2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • Mikhail S, Lustberg MB, Ruppert AS, Mortazavi A, Monk P, Kleiber B, Villalona-Calero M, Bekaii-Saab T. Biomodulation of capecitabine by paclitaxel and carboplatin in advanced solid tumors and adenocarcinoma of unknown primary. Cancer Chemother Pharmacol. 2015 Nov;76(5):1005-12. doi: 10.1007/s00280-015-2877-6. Epub 2015 Sep 28.

    PMID: 26416564BACKGROUND

Related Links

MeSH Terms

Conditions

NeoplasmsNeoplasms, Unknown PrimaryAdenocarcinoma

Interventions

CapecitabineCarboplatinPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCoordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Results Point of Contact

Title
Tanios Bekaii-Saab, MD
Organization
The Ohio State University Comprehensive Cancer Center
tanios.bekaii-saab@osumc.edu
614-293-9863

Study Officials

  • Tony Bekaii-Saab

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

June 1, 2005

Primary Completion

November 1, 2007

Study Completion

June 1, 2013

Last Updated

September 23, 2016

Results First Posted

June 1, 2016

Record last verified: 2016-08

Locations

US(1)