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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00462397
First received: April 18, 2007
Last updated: August 23, 2013
Last verified: April 2007
History of Changes
  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: neoadjuvant therapy
Radiation: brachytherapy
Radiation: radiation therapy
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: April 18, 2007
Last Updated: August 23, 2013
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

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

ClinicalTrials.gov processed this record on September 28, 2016