Suspended

Weekly Docetaxel and Carboplatin in Patients With Recurrent Squamous Carcinoma of the Cervix: A Phase I/II Study

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Urogenital Diseases+13

+ Genital Diseases

+ Carcinoma

From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: November 2003
See protocol details

Summary

Principal SponsorWake Forest University Health Sciences
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2003

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the maximum tolerated dose of docetaxel when administered with carboplatin in patients with recurrent stage IVB squamous cell carcinoma of the cervix. * Determine the response rate and time to progression in patients treated with this regimen. Secondary * Determine the toxicity of this regimen in these patients. * Determine the quality of life of patients treated with this regimen. OUTLINE: This is phase I, dose-escalation study of docetaxel followed by a phase II study. * Phase I: Patients receive docetaxel IV over 30 minutes and carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients who demonstrate continuing tumor shrinkage after 6 courses receive 2 additional courses beyond their best response. Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. * Phase II: Patients receive docetaxel and carboplatin as in phase I at the MTD determined in phase I. Quality of life is assessed at baseline, before every other course of treatment, and at the end of study treatment. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for phase I and 16-40 for phase II) will be accrued for this study within 2 years.

Official TitleWeekly Docetaxel and Carboplatin in Patients With Recurrent Squamous Carcinoma of the Cervix: A Phase I/II Study 
NCT00084890
Principal SponsorWake Forest University Health Sciences
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesCarcinomaUterine Cervical DiseasesUterine Cervical NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsFemale Urogenital Diseases

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Wake Forest University Comprehensive Cancer Center

Winston-Salem, United StatesSee the location
SuspendedOne Study Center