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

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ClinicalTrials.gov Identifier: NCT00462397

Recruitment Status : Unknown

Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was: Recruiting

First Posted : April 19, 2007

Last Update Posted : August 26, 2013

Sponsor:

Information provided by:

National Cancer Institute (NCI)

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 (Clinical Trial)
Estimated 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 :	June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

U.S. FDA Resources

Arms and Interventions

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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462397

Locations


United Kingdom
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


ClinicalTrials.gov Identifier:	NCT00462397 History of Changes
Other Study ID Numbers:	CDR0000540233 UCLCTC-BRD/05/22-CERVIX EUDRACT-2005-000134-20 CRUK-BRD/05/22 EU-20720 UCLCTC-CERVIX
First Posted:	April 19, 2007 Key Record Dates
Last Update Posted:	August 26, 2013
Last Verified:	April 2007

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

Additional relevant MeSH terms:


Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Paclitaxel	Albumin-Bound Paclitaxel Cisplatin Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action

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