Docetaxel and Carboplatin in Treating Patients With Recurrent Stage IVB Squamous Cell Carcinoma (Cancer) of the Cervix
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Drug: carboplatin Drug: docetaxel |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Weekly Docetaxel and Carboplatin in Patients With Recurrent Squamous Carcinoma of the Cervix: A Phase I/II Study |
- Maximum tolerated dose of docetaxel [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 15 |
| Study Start Date: | November 2003 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
-
Drug: carboplatin
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1065 | |
| Study Chair: | Brigitte E. Miller, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT00084890 History of Changes |
| Other Study ID Numbers: | CDR0000366942, CCCWFU-30102B, NCI-6949 |
| Study First Received: | June 10, 2004 |
| Last Updated: | July 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Comprehensive Cancer Center of Wake Forest University:
|
stage IVB cervical cancer recurrent cervical cancer cervical squamous cell carcinoma |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Uterine Cervical Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Docetaxel Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013