Status:
UNKNOWN
Paclitaxel and Carboplatin Followed by Cisplatin and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer
Lead Sponsor:
University College London Hospitals
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 di...
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 w...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00462397
Start Date
June 1 2005
Last Update
August 26 2013
Active Locations (3)
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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