search
Back to results

Paclitaxel, Topotecan, and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
cisplatin
paclitaxel
topotecan hydrochloride
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring cervical squamous cell carcinoma, stage III cervical cancer, recurrent cervical cancer, cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical small cell carcinoma, stage IVA cervical cancer, stage IVB cervical cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Advanced, persistent, or recurrent squamous or nonsquamous cell carcinoma of the cervix with documented disease progression Histologic confirmation of the original primary tumor is required Disease must be measurable in at least one dimension by conventional techniques, including palpation, plain x-ray, CT scan, or MRI Measurable disease is defined as at least one lesion that can be accurately measured Each lesion must be ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiation therapy PATIENT CHARACTERISTICS: GOG performance status 0-2 Platelet count ≥ 100,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Creatinine ≤ 1.5 times upper limit of normal (ULN) Bilirubin ≤ 1.5 times ULN SGOT and alkaline phosphatase ≤ 2.5 times ULN Neuropathy (sensory and motor) ≤ grade 1 No active infection requiring antibiotics No evidence of more than one malignancy present within the past 5 years Nonmelanoma skin cancer allowed Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: No prior therapy with cytotoxic drugs for advanced or recurrent cervical carcinoma Prior cisplatin as a radiosensitizer for primary treatment of disease allowed No previous cancer treatment that contraindicates study treatment No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the treatment of cervical cancer No prior chemotherapy for any abdominal or pelvic tumor except for the treatment of cervical cancer Recovered from effects of recent surgery, radiotherapy, or other therapy At least 4 weeks since prior radiotherapy More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin and free of recurrent or metastatic disease More than 3 years since prior adjuvant chemotherapy for localized breast cancer provided patient is free of recurrent or metastatic disease No hormonal therapy directed at the malignant tumor within the past week Concurrent hormone replacement therapy is permitted No concurrent amifostine or other protective reagents

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The frequency and duration of objective response
    The frequency and severity of observed adverse effects

    Secondary Outcome Measures

    Progression-free survival and overall survival
    Prognostic factor: prior chemoradiation

    Full Information

    First Posted
    January 12, 2006
    Last Updated
    May 24, 2013
    Sponsor
    Gynecologic Oncology Group
    Collaborators
    National Cancer Institute (NCI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00276796
    Brief Title
    Paclitaxel, Topotecan, and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
    Official Title
    A Limited Access Phase II Trial of Weekly Topotecan (NSC #609699), Paclitaxel (NSC #673089), and Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Gynecologic Oncology Group
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel together with topotecan and cisplatin works in treating patients with advanced, persistent, or recurrent cervical cancer.
    Detailed Description
    OBJECTIVES: Primary Estimate the antitumor activity of the combination of paclitaxel, topotecan, and cisplatin in patients with advanced, persistent, or recurrent carcinoma of the cervix. Determine the nature and degree of toxicity for this drug regimen in these patients. Secondary Determine the duration of progression-free survival and overall survival. Determine the impact of prior chemoradiation on response to treatment. OUTLINE: This is an open-label study. Patients receive paclitaxel IV over 1 hour followed by topotecan IV over 30 minutes and cisplatin IV over 1 hour on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 5 years. PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer
    Keywords
    cervical squamous cell carcinoma, stage III cervical cancer, recurrent cervical cancer, cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical small cell carcinoma, stage IVA cervical cancer, stage IVB cervical cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Masking
    None (Open Label)
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    cisplatin
    Intervention Type
    Drug
    Intervention Name(s)
    paclitaxel
    Intervention Type
    Drug
    Intervention Name(s)
    topotecan hydrochloride
    Primary Outcome Measure Information:
    Title
    The frequency and duration of objective response
    Title
    The frequency and severity of observed adverse effects
    Secondary Outcome Measure Information:
    Title
    Progression-free survival and overall survival
    Title
    Prognostic factor: prior chemoradiation

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Advanced, persistent, or recurrent squamous or nonsquamous cell carcinoma of the cervix with documented disease progression Histologic confirmation of the original primary tumor is required Disease must be measurable in at least one dimension by conventional techniques, including palpation, plain x-ray, CT scan, or MRI Measurable disease is defined as at least one lesion that can be accurately measured Each lesion must be ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiation therapy PATIENT CHARACTERISTICS: GOG performance status 0-2 Platelet count ≥ 100,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Creatinine ≤ 1.5 times upper limit of normal (ULN) Bilirubin ≤ 1.5 times ULN SGOT and alkaline phosphatase ≤ 2.5 times ULN Neuropathy (sensory and motor) ≤ grade 1 No active infection requiring antibiotics No evidence of more than one malignancy present within the past 5 years Nonmelanoma skin cancer allowed Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: No prior therapy with cytotoxic drugs for advanced or recurrent cervical carcinoma Prior cisplatin as a radiosensitizer for primary treatment of disease allowed No previous cancer treatment that contraindicates study treatment No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the treatment of cervical cancer No prior chemotherapy for any abdominal or pelvic tumor except for the treatment of cervical cancer Recovered from effects of recent surgery, radiotherapy, or other therapy At least 4 weeks since prior radiotherapy More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin and free of recurrent or metastatic disease More than 3 years since prior adjuvant chemotherapy for localized breast cancer provided patient is free of recurrent or metastatic disease No hormonal therapy directed at the malignant tumor within the past week Concurrent hormone replacement therapy is permitted No concurrent amifostine or other protective reagents
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Harry J. Long, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Paclitaxel, Topotecan, and Cisplatin in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

    We'll reach out to this number within 24 hrs