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Docetaxel and Carboplatin in Treating Patients With Recurrent Stage IVB Squamous Cell Carcinoma (Cancer) of the Cervix

Primary Purpose

Cervical Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
carboplatin
docetaxel
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring stage IVB cervical cancer, recurrent cervical cancer, cervical squamous cell carcinoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Maximum tolerated dose of docetaxel

Secondary Outcome Measures

Full Information

First Posted
June 10, 2004
Last Updated
August 8, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00084890
Brief Title
Docetaxel and Carboplatin in Treating Patients With Recurrent Stage IVB Squamous Cell Carcinoma (Cancer) of the Cervix
Official Title
Weekly Docetaxel and Carboplatin in Patients With Recurrent Squamous Carcinoma of the Cervix: A Phase I/II Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
November 2003 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
stage IVB cervical cancer, recurrent cervical cancer, cervical squamous cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
30 minute infusion dosed based on glomerular filtration rate of patient
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
escalating doses ofstarting at 25 milligrams per meter squared
Primary Outcome Measure Information:
Title
Maximum tolerated dose of docetaxel
Time Frame
28 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte E. Miller, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1065
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Docetaxel and Carboplatin in Treating Patients With Recurrent Stage IVB Squamous Cell Carcinoma (Cancer) of the Cervix

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