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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


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer

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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 CenterCleveland, Ohio  44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037