Paclitaxel and Carboplatin Followed by Cisplatin and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer
Paclitaxel and Carboplatin Followed by Cisplatin and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work
 in different ways to stop the growth of tumor cells, either by killing the cells or by
 stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells.
 Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

 PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin
 followed by cisplatin and radiation therapy works in treating patients with stage IB, stage
 II, stage III, or stage IVA cervical cancer.
OBJECTIVES:

 Primary

 -  Determine the response rate, in terms of clinical or radiologic response at 12 weeks
 after completion of study therapy, in patients with stage IB2-IVA cervical cancer
 treated with neoadjuvant chemotherapy comprising dose-dense paclitaxel and carboplatin
 followed by radical chemoradiotherapy comprising concurrent cisplatin and radiotherapy.

 Secondary

 -  Determine the response rate in patients treated with this neoadjuvant chemotherapy
 regimen.

 -  Determine the toxicity of this neoadjuvant chemotherapy regimen in these patients.

 -  Assess the progression-free survival of patients treated with this regimen.

 -  Determine the overall survival of patients treated with this regimen.

 OUTLINE: This is a multicenter study.

 -  Neoadjuvant chemotherapy: Patients receive neoadjuvant chemotherapy comprising
 paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats
 weekly for up to 6 courses in the absence of disease progression or unacceptable
 toxicity.

 -  Chemoradiotherapy: Beginning in week 7, or as soon as blood counts recover, patients
 receive cisplatin IV over 1 hour on day 1. Treatment repeats weekly for 4-6 courses in
 the absence of disease progression or unacceptable toxicity. Patients also undergo
 concurrent radiotherapy comprising pelvic external beam radiotherapy once daily for 5½
 weeks (5 weeks for patients with positive para-aortic lymph nodes) and 2 applications of
 high-dose rate intracavitary brachytherapy or low- or medium-dose rate brachytherapy.
 Patients with parametrial or pelvic sidewall disease extension also undergo external
 boost radiotherapy for 3 days.

 After completion of study therapy, patients are followed periodically for 2 years.

 PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
DISEASE CHARACTERISTICS:

 -  Histologically confirmed carcinoma of the cervix, including any of the following
 subtypes:

 -  Squamous cell carcinoma

 -  Adenocarcinoma

 -  Adenosquamous cell carcinoma

 -  Locally advanced disease (i.e., FIGO stage IB2-IVA disease)

 -  Stage confirmed by examination under anesthesia, cystoscopy, and sigmoidoscopy
 with biopsy of any suspicious lesions in the bladder, vagina, or rectum

 -  Disease suitable for treatment with radical intent using chemoradiotherapy

 PATIENT CHARACTERISTICS:

 -  ECOG performance status 0-1

 -  Platelet count > 100,000/mm^3

 -  Hemoglobin > 12.5 g/dL

 -  WBC > 3,000/mm^3

 -  Absolute neutrophil count > 1,500/mm^3

 -  Bilirubin < 1.25 times upper limit of normal (ULN)

 -  Glomerular filtration rate (GFR) normal by ethylenediaminetetraacetic acid (EDTA) OR
 creatinine clearance ≥ 60 mL/min

 -  Placement of ureteric stents required for all patients with hydronephrosis, regardless
 of renal function

 -  ALT or AST < 2.5 times ULN

 -  Not pregnant or nursing

 -  Negative pregnancy test

 -  No prior diagnosis of cancer, except basal cell skin cancer

 -  No active cardiac disease

 -  Deemed fit to receive chemoradiotherapy

 -  ECG normal

 PRIOR CONCURRENT THERAPY:

 -  Not specified