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A Phase II Evaluation of Weekly Topotecan Hydrochloride (Hycamtin®, NSC #609699) in the Treatment of Persistent or Recurrent Carcinoma of the Cervix


Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

A Phase II Evaluation of Weekly Topotecan Hydrochloride (Hycamtin®, NSC #609699) in the Treatment of Persistent or Recurrent Carcinoma of the Cervix


OBJECTIVES:

- Determine the antitumor activity of topotecan in patients with persistent or recurrent
carcinoma of the cervix that failed higher priority treatment protocols.

- Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.

Patient are followed for every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 1-2
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed carcinoma of the cervix

- Squamous cell or nonsquamous cell

- Persistent or recurrent disease

- Documented disease progression

- Measurable disease

- At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional
techniques OR ≥ 10 mm by spiral CT scan

- Tumors within a previously irradiated field are considered non-target lesions
unless disease progression is documented or a biopsy is obtained to confirm
persistent disease at least 90 days after completion of prior radiotherapy

- Must have received 1 prior systemic chemotherapy regimen for persistent or recurrent
squamous cell or nonsquamous cell carcinoma of the cervix

- Chemotherapy administered with primary radiotherapy as a radiosensitizer is not
considered a systemic chemotherapy regimen

- Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG
protocol for the same patient population)

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- GOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

Renal

- Creatinine ≤ 1.5 times ULN

Other

- Sensory or motor neuropathy ≤ grade 1

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infection requiring antibiotics

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent
disease allowed, including, but not limited to, the following:

- Monoclonal antibodies

- Cytokines

- Small-molecule inhibitors of signal transduction

- At least 3 weeks since prior biologic or immunologic agents for cervical cancer

- No concurrent prophylactic growth factors, including filgrastim (G-CSF), sargramostim
(GM-CSF), or pegfilgrastim

- No concurrent prophylactic thrombopoietic agents

Chemotherapy

- See Disease Characteristics

- Recovered from prior chemotherapy

- No more than 1 prior cytotoxic chemotherapy regimen (either with single or
combination cytotoxic drug therapy)

- No prior topotecan

Endocrine therapy

- At least 1 week since prior hormonal therapy for cervical cancer

- Concurrent hormone replacement therapy allowed

Radiotherapy

- See Disease Characteristics

- Recovered from prior radiotherapy

Surgery

- Recovered from prior surgery

Other

- At least 3 weeks since other prior therapy for cervical cancer

- No prior cancer therapy that would preclude study participation

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity

Safety Issue:

No

Principal Investigator

James V. Fiorica, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sarasota Memorial Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000372930

NCT ID:

NCT00087126

Start Date:

February 2005

Completion Date:

Related Keywords:

  • Cervical Cancer
  • recurrent cervical cancer
  • cervical squamous cell carcinoma
  • Uterine Cervical Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Kaiser Permanente Medical Center - Los AngelesLos Angeles, California  90027
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cancer Care Associates - Midtown TulsaTulsa, Oklahoma  74104
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Yale Cancer CenterNew Haven, Connecticut  06520-8028
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Helen and Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut  06102-5037
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Lakeland Regional Cancer Center at Lakeland Regional Medical CenterLakeland, Florida  33805
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Lurleen Wallace Comprehensive Cancer at University of Alabama - BirminghamBirmingham, Alabama  35294
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Olive View - UCLA Medical Center FoundationSylmar, California  91342