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

Sponsor

University College London Hospitals (Other)

Overall Status

Unknown status

CT.gov ID

NCT00462397

Collaborator

(none)

Enrollment

Locations

16.7

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Drug: carboplatin Drug: cisplatin Drug: paclitaxel Procedure: neoadjuvant therapy Radiation: brachytherapy Radiation: radiation therapy	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Study of Weekly Neoadjuvant Chemotherapy Followed by Radical Chemoradiation for Locally Advanced Cervical Cancer

Study Start Date :

Jun 1, 2005

Outcome Measures

Primary Outcome Measures

Response rate at the end of chemoradiotherapy (i.e., 12 weeks after completion of study therapy) []

Secondary Outcome Measures

Response rate at the end of neoadjuvant treatment (i.e., 6 weeks after study entry) []
Toxicity as assessed by NCI CTCAE v3.0 []
Progression-free survival []
Overall survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leicester Royal Infirmary	Leicester	England	United Kingdom	LE1 5WW
2	Royal Marsden - London	London	England	United Kingdom	SW3 6JJ
3	University College of London Hospitals	London	England	United Kingdom	WIT 3AA