A Phase I Evaluation of Extended Field Radiation Therapy With Concomitant Cisplatin Chemotherapy Followed by Paclitaxel and Carboplatin Chemotherapy in Women With Cervical Carcinoma Metastatic to the Para-Aortic Lymph Nodes
18 Years
N/A
Female
Cervical Cancer
Trial Information
A Phase I Evaluation of Extended Field Radiation Therapy With Concomitant Cisplatin Chemotherapy Followed by Paclitaxel and Carboplatin Chemotherapy in Women With Cervical Carcinoma Metastatic to the Para-Aortic Lymph Nodes
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum-tolerated dose (MTD) of adjuvant carboplatin and paclitaxel
Safety Issue:
Yes
Principal Investigator
Cecelia H. Boardman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massey Cancer Center
Authority:
Unspecified
Study ID:
CDR0000695304
NCT ID:
NCT01295502
Start Date:
May 2011
Completion Date:
Related Keywords:
- Cervical Cancer
- 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
- Uterine Cervical Neoplasms
Name | Location |
|---|---|
| Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
| Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
| Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
