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

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