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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
Not Enrolling
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


- 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

Inclusion Criteria


- 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)



- 18 and over

Performance status

- GOG 0-2

Life expectancy

- Not specified


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

- Platelet count ≥ 100,000/mm^3


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

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN


- Creatinine ≤ 1.5 times ULN


- 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


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


- 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


- See Disease Characteristics

- Recovered from prior radiotherapy


- Recovered from prior surgery


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

- No prior cancer therapy that would preclude study participation

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity

Safety Issue:


Principal Investigator

James V. Fiorica, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sarasota Memorial Hospital


United States: Federal Government

Study ID:




Start Date:

February 2005

Completion Date:

Related Keywords:

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



University of Chicago Cancer Research Center Chicago, Illinois  60637
Duke Comprehensive Cancer Center Durham, North Carolina  27710
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain, Connecticut  06050
Kaiser Permanente Medical Center - Los Angeles Los Angeles, California  90027
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Cancer Care Associates - Midtown Tulsa Tulsa, Oklahoma  74104
Women and Infants Hospital of Rhode Island Providence, Rhode Island  02905
Yale Cancer Center New Haven, Connecticut  06520-8028
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
William Beaumont Hospital - Royal Oak Campus Royal Oak, Michigan  48073
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Helen and Harry Gray Cancer Center at Hartford Hospital Hartford, Connecticut  06102-5037
Mount Carmel Health - West Hospital Columbus, Ohio  43222
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240
Lakeland Regional Cancer Center at Lakeland Regional Medical Center Lakeland, Florida  33805
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Regional Cancer Center at Singing River Hospital Pascagoula, Mississippi  39581
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham Birmingham, Alabama  35294
Saint Louis University Cancer Center Saint Louis, Missouri  63110
Olive View - UCLA Medical Center Foundation Sylmar, California  91342