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Study of Cisplatin in Cervical Cancer Stage IVB

Primary Purpose

Cervical Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cisplatin Combined With Topotecan
Sponsored by
Chinese Anti-Cancer Association
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Response rate (CR + PR) (RECIST)

    Secondary Outcome Measures

    Toxicity [NCI CTCAE (Version 3.0)]

    Full Information

    First Posted
    January 16, 2009
    Last Updated
    January 20, 2009
    Sponsor
    Chinese Anti-Cancer Association
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00826891
    Brief Title
    Study of Cisplatin in Cervical Cancer Stage IVB
    Official Title
    Phase II Study of Cisplatin Combined With Topotecan in Advanced (Stage IVB) Recurrent or Persistent Cervical Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2009 (undefined)
    Primary Completion Date
    January 2010 (Anticipated)
    Study Completion Date
    January 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Chinese Anti-Cancer Association

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Cisplatin Combined With Topotecan
    Intervention Description
    Patients must have specific minimum neutrophil and platelet counts before administration of Hycamtin. The dose of Hycamtin is 0.75 mg/m2 by intravenous infusion over 30 minutes daily on days 1, 2, and 3; followed by cisplatin 50 mg/m2 by intravenous infusion on day 1 repeated every 21 days (a 21-day course). Dosage adjustments for subsequent courses of Hycamtin in combination with cisplatin are specific for each drug. Dose levels for cisplatin Initial dose 0 = 50 mg/m2 Dose reduction level -1 = 37.5 mg/m2 Dose reduction level -2 = 25 mg/m2 Dose levels for topotecan Initial dose 0 = 0.75 mg/m2 Dose reduction level -1 = 0.60 mg/m2 Dose reduction level -2 = 0.45 mg/m2
    Primary Outcome Measure Information:
    Title
    Response rate (CR + PR) (RECIST)
    Time Frame
    4~6 weeks after the end of treatment
    Secondary Outcome Measure Information:
    Title
    Toxicity [NCI CTCAE (Version 3.0)]
    Time Frame
    4~6 weeks after the end of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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    Study of Cisplatin in Cervical Cancer Stage IVB

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