| Conditions: |
|
Cervical Cancer |
| Purpose: |
|
RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, 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 paclitaxel and carboplatin (combination chemotherapy) after cisplatin and radiation
therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying cisplatin and radiation therapy followed by
paclitaxel and carboplatin in treating patients with stage I, stage II, stage III, or stage
IV cervical cancer.
|
| Study Summary: |
|
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLT) of
adjuvant carboplatin and paclitaxel chemotherapy following concurrent weekly cisplatin
chemotherapy and extended-field radiation in women with newly diagnosed Stage IB-IVA
cervical cancer, with positive para-aortic nodes.
- To determine the feasibility of the treatment regimen over the four courses of adjuvant
chemotherapy once the MTD is estimated.
- To assess the toxicities of the treatment regimen according to the NCI Common
Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Secondary
- To assess the response rate to this treatment regimen in patients with measurable
disease.
- To examine progression-free survival at one year on this treatment regimen.
- To examine overall survival.
- To estimate the frequency of chronic toxicities experienced within one year of study
entry.
OUTLINE: This is a multicenter, dose-escalation study of carboplatin and paclitaxel.
Patients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 and undergo extended-field
radiotherapy (including brachytherapy) once daily, 5 days a week, for 6 weeks.
Beginning 4-6 weeks after completion of chemoradiation, patients receive adjuvant
chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on
day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression
or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 1 year.
|
| Criteria: |
|
DISEASE CHARACTERISTICS:
- Patients with histologically confirmed cervical cancer (squamous, adenocarcinoma, or
adenosquamous)
- FIGO Clinical stages IB, IIA, IIB, IIIA, IIIB, IVA, with positive para-aortic
lymph nodes confirmed by PET/CT scan, fine-needle biopsy, extraperitoneal
biopsy, laparoscopic biopsy, or lymphadenectomy
- Scalene node sampling is NOT required
PATIENT CHARACTERISTICS:
- GOG performance status 0-2
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine normal OR creatinine clearance > 50 mL/min
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Peripheral neuropathy (sensory and motor) ≤ grade 1
- Patients of child-bearing potential must have a negative serum pregnancy test prior
to study entry (within 72 hours prior to initiation of study treatment) and be
practicing an effective form of contraception
- No active infection
- No circumstances that will not permit completion of this study or the required
follow-up
- No renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal
transplantation, that would require modification of radiation fields
- Patients with ureteral obstruction must undergo stent or nephrostomy tube placement
prior to study entry
- No history of other invasive malignancies within the past 5 years except non-melanoma
skin cancer
- No significant history of cardiac disease, (i.e., uncontrolled hypertension, unstable
angina, congestive heart failure, or uncontrolled arrhythmias) within the past 6
months
- No known sensitivity reactions to products containing Cremaphor® EL
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior pelvic or abdominal radiotherapy, cytotoxic chemotherapy, or therapy of any
kind for this malignancy
- No prior cancer treatment that contraindicates this protocol therapy
- No major surgery, excluding diagnostic biopsy, within the past 30 days (to allow for
full recovery)
- No other concurrent investigational agent
- No concurrent intensity-modulated radiotherapy or helical tomotherapy
- Patients may NOT receive amifostine or other protective reagents
|
| NCT ID: |
|
NCT01295502 |
| Primary Contact: |
|
Principal Investigator
Cecelia H. Boardman, MD
Massey Cancer Center
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Richmond, Virginia 23298
United States
Clinical Trials Office -Virginia Commonwealth University Masse
Phone: 804-628-1939
Site Status: Recruiting |