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

Sponsored by:	University College London Hospitals
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00462397

Purpose

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	Intervention	Phase
Cervical Cancer	Drug: carboplatin Drug: cisplatin Drug: paclitaxel Procedure: brachytherapy Procedure: neoadjuvant therapy Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Carboplatin Cisplatin Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Study of Weekly Neoadjuvant Chemotherapy Followed by Radical Chemoradiation for Locally Advanced Cervical Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate at the end of chemoradiotherapy (i.e., 12 weeks after completion of study therapy) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate at the end of neoadjuvant treatment (i.e., 6 weeks after study entry) [ Designated as safety issue: No ]
Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Progression-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	June 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462397

Locations

United Kingdom, England
Leicester Royal Infirmary	Recruiting
Leicester, England, United Kingdom, LE1 5WW
Contact: R. Paul Symonds, MD, FRCP, FRCR 44-116-258-6296
Royal Marsden - London	Recruiting
London, England, United Kingdom, SW3 6JJ
Contact: Peter R. Blake, MD 44-20-7808-2581 peter.blake@rmh.nthames.nhs.uk
University College of London Hospitals	Recruiting
London, England, United Kingdom, WIT 3AA
Contact: Mary McCormack, MD 44-20-7380-9302

Sponsors and Collaborators

University College London Hospitals

Investigators

Study Chair:

Mary McCormack, MD

University College London Hospitals

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000540233, UCLCTC-BRD/05/22-CERVIX, EUDRACT-2005-000134-20, CRUK-BRD/05/22, EU-20720, UCLCTC-CERVIX
Study First Received:	April 18, 2007
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00462397
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma
stage IB cervical cancer
stage IIA cervical cancer

stage IIB cervical cancer
stage III cervical cancer
stage IVA cervical cancer
recurrent cervical cancer

Study placed in the following topic categories:

Epidermoid carcinoma
Cisplatin
Paclitaxel
Squamous cell carcinoma
Carcinoma, squamous cell
Carboplatin

Adenocarcinoma
Carcinoma, Squamous Cell
Carcinoma, Adenosquamous
Recurrence
Carcinoma

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators

Tubulin Modulators
Physiological Effects of Drugs
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009