Paclitaxel and Carboplatin Followed by Cisplatin and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College London Hospitals
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Paclitaxel

Criteria

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