NCT00354601

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving docetaxel together with carboplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel together with capecitabine works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2006

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

January 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 18, 2009

Completed
Last Updated

August 30, 2017

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

July 19, 2006

Results QC Date

March 9, 2009

Last Update Submit

July 31, 2017

Conditions

Fallopian Tube CancerOvarian CancerPeritoneal Cavity Cancer

Keywords

fallopian tube cancerperitoneal cavity cancerrecurrent ovarian epithelial cancerovarian clear cell cystadenocarcinomaovarian endometrioid adenocarcinomaovarian mucinous cystadenocarcinomaovarian serous cystadenocarcinomaovarian undifferentiated adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Objective Tumor Response

    The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines

    8 weeks

Secondary Outcomes (3)

  • Time to Progression

    Evaluated every 8 weeks during treatment

  • Number of Participants With Grade 3 or Higher Toxicity

    Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy)

  • Quality of Life

    Pre-entry, day 1, treatment end

Study Arms (1)

Weekly Docetaxel and Capecitabine

EXPERIMENTAL

Weekly Docetaxel and Capecitabine

Drug: capecitabineDrug: docetaxel

Interventions

capecitabineDRUG

oral capecitabine twice daily on days 1-21

Weekly Docetaxel and Capecitabine
docetaxelDRUG

docetaxel IV over 30 minutes on days 1, 8, and 15

Weekly Docetaxel and Capecitabine

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DISEASE CHARACTERISTICS:
  • Diagnosis of 1 of the following:
  • Ovarian epithelial adenocarcinoma
  • Fallopian tube cancer
  • Peritoneal cavity cancer
  • Recurrent or persistent disease after no more than 2 prior treatment regimens (1 regimen for primary disease and/or 1 regimen for recurrent disease)
  • Platinum-resistant disease, defined as 1 of the following:
  • Treatment-free interval \< 6 months after platinum-based therapy
  • Disease progression during platinum-based therapy
  • Measurable disease by physical exam, chest x-ray, CT scan, or MRI
  • No brain metastases
  • PATIENT CHARACTERISTICS:
  • Gynecologic Oncology Group performance status 0-2
  • Life expectancy \> 6 months
  • Absolute neutrophil count ≥ 1,500/mm³
  • +30 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

CapecitabineDocetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Limitations and Caveats

Early closure due to discontinuation of funding

Results Point of Contact

Title
Doug Case Biostatistician
Organization
Wake Forest University Health Sciences
dcase@wfubmc.edu
336-716-1048

Study Officials

  • Brigitte E. Miller, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2006

First Posted

July 20, 2006

Study Start

January 1, 2006

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

August 30, 2017

Results First Posted

May 18, 2009

Record last verified: 2017-03

Locations

US(1)