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Phase II Study of Cisplatin Combined With Topotecan in Advanced (Stage IVB) Recurrent or Persistent Cervical Cancer

Phase 2
18 Years
Not Enrolling
Cervical Cancer

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Trial Information

Phase II Study of Cisplatin Combined With Topotecan in Advanced (Stage IVB) Recurrent or Persistent Cervical Cancer

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (CR + PR) (RECIST)

Outcome Time Frame:

4~6 weeks after the end of treatment

Safety Issue:



China: Food and Drug Administration

Study ID:




Start Date:

February 2009

Completion Date:

January 2010

Related Keywords:

  • Cervical Cancer
  • Uterine Cervical Neoplasms