Phase II Study of Cisplatin Combined With Topotecan in Advanced (Stage IVB) Recurrent or Persistent Cervical Cancer
- women with advanced recurrent or persistent carcinoma of the uterine cervical who
were unsuitable candidates for curative treatment with surgery and/or radiotherapy.
- Histologic types included squamous, adenosquamous, and adenocarcinoma of the cervia.
- Patients must be at least 18 years old.
- Measurable and/or evaluable disease parameters will be documented and recorded using
clinical evaluation (and using CT for pathologic nodes when present).
- Life expectation greater than 3 months.
- Patients must have adequate organ function.
- Patients without history of sensitivity to camptothecin or platinum.
- Patients who are non-child-bearing potential, or consistent and correct use of
methods of birth control from 2 weeks prior to administration of the first dose of
study medication until 28 days after the final dose of observational medication.
- performance status 0 to 2; to have recovered from the effects of recent surgery,
chemoradiotherapy, or radiotherapy; and to be free of clinically significant
- Written informed consent
- Patients with uncontrolled infections.
- Patients with concurrent severe medical problems unrelated to the malignancy which
would expose the patient to extreme risk.
- Patients who received another investigational drug within 30 days prior to study
- Patients who are receiving concurrent other chemotherapy, hormonal, immunotherapy or
radiotherapy. Radiotherapy for palliation of related bone metastases is permitted.
- Patients with a history of allergic reactions to compounds chemically related to
topotecan or platinum.
- Patients who are pregnant or lactating
- Concomitant malignancies or previous malignancies within the last five years, with
the exception of adequately treated basal or squamous cell carcinoma of the skin.