Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Gynecologic Oncology Group
Study ID
NCT00064077
Phase
PHASE3
Status
Completed

Conditions

  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Carcinoma
  • Cervical Squamous Cell Carcinoma
  • Recurrent Cervical Carcinoma
  • Stage IVB Cervical Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    Given IV
  • Gemcitabine Hydrochloride — DRUG
  • Paclitaxel — DRUG
    Given IV
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Topotecan Hydrochloride — DRUG
    Given IV
  • Vinorelbine Tartrate — DRUG
    Given IV

Study Details

This randomized phase III trial is studying four combination chemotherapy regimens using cisplatin to compare how well they work in treating women with stage IVB, recurrent, or persistent cancer of the cervix. Drugs used in chemotherapy such as cisplatin, paclitaxel, vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen containing cisplatin is most effective in treating cervical cancer.

Key Dates

Start date
May 31, 2003
Status verified
Aug 2018
Primary completion
Jan 31, 2011
Completion
Jan 30, 2018

Study Design

Enrollment
513 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (paclitaxel, cisplatin)
    Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.
  • Experimental: Arm II (vinorelbine, cisplatin)
    Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.
  • Experimental: Arm III (gemcitabine, cisplatin)
    Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.
  • Experimental: Arm IV (topotecan, cisplatin)
    Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.

Primary Outcome Measure

Duration of Overall Survival (OS) [ Time Frame: Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Gynecologic Oncology GroupPhiladelphiaPennsylvania19103-

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Gynecologic Oncology Group· Philadelphia, PA

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