NCT00084890

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining docetaxel with carboplatin may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given together with carboplatin and to see how well they work in treating patients with recurrent stage IVB squamous cell carcinoma (cancer) of the cervix.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2003

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

November 1, 2003

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2004

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

3.3 years

First QC Date

June 10, 2004

Last Update Submit

August 8, 2018

Conditions

Cervical Cancer

Keywords

stage IVB cervical cancerrecurrent cervical cancercervical squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose of docetaxel

    28 days

Interventions

carboplatinDRUG

30 minute infusion dosed based on glomerular filtration rate of patient

docetaxelDRUG

escalating doses ofstarting at 25 milligrams per meter squared

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the uterine cervix * Advanced disease (stage IVB) * Persistent or recurrent disease * No available curative treatment options * Measurable disease by physical examination, chest x-ray, CT scan, or MRI PATIENT CHARACTERISTICS: Age * Over 18 Performance status * GOG 0-2 Life expectancy * More than 6 months Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 8 g/dL Hepatic * Bilirubin normal * SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal OR * Alkaline phosphatase ≤ 4 times ULN AND SGOT and SGPT normal Renal * Creatinine \< 1.5 times ULN Other * No other invasive malignancy within the past 5 years * No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * No peripheral neuropathy \> grade 1 * No other concurrent malignancy except curatively treated non-melanoma skin cancer * No other serious medical or psychiatric illness that would preclude giving informed consent or limit survival * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent biologic therapy Chemotherapy * No more than 2 prior chemotherapy regimens * One sensitizing chemotherapy regimen during radiotherapy AND 1 regimen for recurrent disease are considered 2 regimens * At least 4 weeks since prior chemotherapy * No prior docetaxel * No prior carboplatin * No other concurrent chemotherapy Endocrine therapy * At least 4 weeks since prior hormonal therapy Radiotherapy * See Chemotherapy * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * At least 3 weeks since prior major surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1065, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

CarboplatinDocetaxel

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Brigitte E. Miller, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2004

First Posted

June 11, 2004

Study Start

November 1, 2003

Primary Completion

March 1, 2007

Study Completion

April 1, 2010

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

US(1)