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Clinical Trials/NCT00826891
NCT00826891UnknownPhase 2

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

Chinese Anti-Cancer Association0 sites40 target enrollmentStarted: February 1, 2009Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Sponsor
Enrollment
40
Primary Endpoint
Response rate (CR + PR) (RECIST)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This is a single arm, open-label study in women from China who have Advanced (stage IVB) Recurrent or Persistent cervical cancer to ⑴assess the response rate (i.e., CR + PR) of Cisplatin combined with Topotecan in treatment of advanced (stage IVB) recurrent or persistent Cervical cancer; ⑵assess the toxicities of CT regimen in treatment of cervical cancer. Prior to treatment, written informed consent should be obtained from all patients. Eligible patients will be assigned to CT regimen. The CT regimen is topotecan 0.75 mg/m2 IV during 30minutes days 1, 2, and 3; followed by cisplatin 50 mg/m2 IV on day1, repeated every 21 days. The study will consist of two phases: the safety run-in phase and study phase.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 infection.
  • •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 entry.
  • •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.

Outcomes

Primary Outcomes

Response rate (CR + PR) (RECIST)

Time Frame: 4~6 weeks after the end of treatment

Secondary Outcomes

  • Toxicity [NCI CTCAE (Version 3.0)](4~6 weeks after the end of treatment)

Investigators

Sponsor
Chinese Anti-Cancer Association
Sponsor Class
Other

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