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

• Status: Terminated
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Comprehensive Cancer Center of Wake Forest University; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Docetaxel

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