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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. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
University College London Hospitals
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
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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:
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)
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
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2005 |
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) |
| 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
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
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 |
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 July 26, 2017