Topotecan in Treating Women With Persistent or Recurrent Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Intervention: topotecan hydrochloride
Intervention MeSH terms: Topotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent cervical cancer; cervical squamous cell carcinoma

Summary:

      RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop
      tumor cells from dividing so they stop growing or die.

      PURPOSE: This phase II trial is studying how well topotecan works in treating women with
      persistent or recurrent cervical cancer.
    

Eligibility 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