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A Randomized Phase III Study of Cisplatin Versus Cisplatin Plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix


Phase 3
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

A Randomized Phase III Study of Cisplatin Versus Cisplatin Plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix


OBJECTIVES:

- Compare the response rate and survival of patients with stage IVB, recurrent, or
persistent carcinoma of the cervix treated with cisplatin only vs cisplatin plus
topotecan vs methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC). (Arm III
(MVAC) closed to accrual effective 07/23/2001.)

- Compare the toxic effects of these regimens in this patient population.

- Compare health-related quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to GOG
performance status. Patients are randomized to one of three treatment arms. (Arm III closed
to accrual effective 07/23/2001.)

- Arm I: Patients receive cisplatin IV once every 21 days.

- Arm II:Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin IV
(beginning after topotecan infusion) on day 1. Courses repeat every 21 days.

- Arm III:Patients receive methotrexate IV on days 1, 15, and 22, vinblastine IV on days
2, 15, and 22, and doxorubicin IV and cisplatin IV on day 2. Courses repeat every 28
days. (Arm III closed to accrual effective 07/23/2001.) Treatment in all arms continues
for a maximum of 6 courses in the absence of disease progression or unacceptable
toxicity. (Arm III closed to accrual effective 07/23/2001.)

Quality of life is assessed before randomization, before course 2, before course 5 (arms I
and II), before course 4 (arm III), and at 9 months. (Arm III closed to accrual effective
07/23/2001.)

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 400 patients (133 per treatment arm) will be accrued for this
study within 2 years. (Arm III closed to accrual effective 07/23/2001.)

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IVB, recurrent, or persistent carcinoma of the cervix
that is not amenable to curative treatment with surgery and/or radiotherapy

- Eligible subtypes:

- Squamous cell carcinoma

- Adenosquamous carcinoma

- Adenocarcinoma

- Measurable disease by physical examination, radiography, CT scan, or MRI

- Measurable disease by CT scan/MRI without biopsy confirmation allowed if lesions
are at least 3 cm and well defined

- No craniospinal metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- GOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal

- Alkaline phosphatase no greater than 3 times normal

Renal:

- Creatinine no greater than 1.5 mg/dL

- No bilateral hydronephrosis that cannot be alleviated by ureteral stents or
percutaneous drainage

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No clinically significant infection

- No other prior invasive malignancy within the past 5 years except nonmelanoma skin
cancer

- Body surface area no greater than 2.0 m^2

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 6 weeks since prior chemoradiotherapy and recovered

- No prior chemotherapy except when used concurrently with radiotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- See Chemotherapy

- At least 3 weeks since prior radiotherapy only and recovered

Surgery:

- Recovered from prior surgery

Other:

- No prior anticancer treatment that would preclude study therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Harry J. Long, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000067138

NCT ID:

NCT00003945

Start Date:

June 1999

Completion Date:

Related Keywords:

  • Cervical Cancer
  • recurrent cervical cancer
  • stage IVB cervical cancer
  • cervical squamous cell carcinoma
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Mercy Cancer Center at Mercy Medical Center-Des MoinesDes Moines, Iowa  50314
Midlands Cancer Center at Midlands Community HospitalPapillion, Nebraska  68128-4157