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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00064077
First received: July 8, 2003
Last updated: May 27, 2015
Last verified: May 2015

July 8, 2003
May 27, 2015
May 2003
January 2011   (final data collection date for primary outcome measure)
  • Quality of life as measured by the FACT-Cervical Trial Outcome of Index and the FACT-Gynecologic Oncology Group/Neurotoxicity subscale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Quality of life as measured by the FACT-Cervical Trial Outcome of Index and the FACT-Gynecologic Oncology Group/Neurotoxicity subscale [ Time Frame: 3 weeks after course 1 ] [ Designated as safety issue: No ]
  • Quality of life as measured by the FACT-Cervical Trial Outcome of Index and the FACT-Gynecologic Oncology Group/Neurotoxicity subscale [ Time Frame: 12 weeks after course 1 ] [ Designated as safety issue: No ]
  • Quality of life as measured by the FACT-Cervical Trial Outcome of Index and the FACT-Gynecologic Oncology Group/Neurotoxicity subscale [ Time Frame: 9 months post-randomization ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00064077 on ClinicalTrials.gov Archive Site
  • Frequency of response [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
  • Pain, assessed by Brief Pain Inventory [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Pain, assessed by Brief Pain Inventory [ Time Frame: 3 weeks after course 1 ] [ Designated as safety issue: No ]
  • Pain, assessed by Brief Pain Inventory [ Time Frame: 12 weeks after course 1 ] [ Designated as safety issue: No ]
  • Pain, assessed by Brief Pain Inventory [ Time Frame: 9 months post-randomization ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix
A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix

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.

PRIMARY OBJECTIVES:

I. Compare the survival and response of patients with stage IVB, recurrent, or persistent carcinoma of the cervix when treated with paclitaxel and cisplatin vs vinorelbine and cisplatin vs gemcitabine and cisplatin vs topotecan and cisplatin.

II. Compare the toxic effects of these regimens in these patients. III. Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms.

ARM I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.

ARM II: Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.

ARM III: Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.

ARM IV: Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.

In all arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before courses 2 and 5, and at 9 months after study entry.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Carcinoma
  • Cervical Squamous Cell Carcinoma
  • Recurrent Cervical Carcinoma
  • Stage IVB Cervical Cancer
  • Drug: Cisplatin
    Given IV
    Other Names:
    • Abiplatin
    • Blastolem
    • Briplatin
    • CDDP
    • Cis-diammine-dichloroplatinum
    • Cis-diamminedichloridoplatinum
    • Cis-diamminedichloro Platinum (II)
    • Cis-diamminedichloroplatinum
    • Cis-dichloroammine Platinum (II)
    • Cis-platinous Diamine Dichloride
    • Cis-platinum
    • Cis-platinum II
    • Cis-platinum II Diamine Dichloride
    • Cismaplat
    • CISPLATIN
    • Cisplatina
    • Cisplatinum
    • Cisplatyl
    • Citoplatino
    • Citosin
    • Cysplatyna
    • DDP
    • Lederplatin
    • Metaplatin
    • Neoplatin
    • Peyrone's Chloride
    • Peyrone's Salt
    • Placis
    • Plastistil
    • Platamine
    • Platiblastin
    • Platiblastin-S
    • Platinex
    • Platinol
    • Platinol- AQ
    • Platinol-AQ
    • Platinol-AQ VHA Plus
    • Platinoxan
    • Platinum
    • Platinum Diamminodichloride
    • Platiran
    • Platistin
    • Platosin
  • Drug: Gemcitabine Hydrochloride
    Other Names:
    • dFdCyd
    • Difluorodeoxycytidine Hydrochloride
    • GEMCITABINE HYDROCHLORIDE
    • Gemzar
    • LY-188011
  • Drug: Paclitaxel
    Given IV
    Other Names:
    • Anzatax
    • Asotax
    • Bristaxol
    • PACLITAXEL
    • Praxel
    • Taxol
    • Taxol Konzentrat
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Drug: Topotecan Hydrochloride
    Given IV
    Other Names:
    • Hycamptamine
    • Hycamtin
    • SKF S-104864-A
    • Topotecan HCl
    • TOPOTECAN HYDROCHLORIDE
    • topotecan hydrochloride (oral)
  • Drug: Vinorelbine Tartrate
    Given IV
    Other Names:
    • Biovelbin
    • Eunades
    • KW-2307
    • Navelbine
    • Navelbine Ditartrate
    • NVB
    • Vinorelbine Ditartrate
    • VINORELBINE TARTRATE
  • 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.
    Interventions:
    • Drug: Cisplatin
    • Drug: Paclitaxel
    • Other: Quality-of-Life Assessment
  • 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.
    Interventions:
    • Drug: Cisplatin
    • Other: Quality-of-Life Assessment
    • Drug: Vinorelbine Tartrate
  • Experimental: Arm III (gemcitabine, cisplatin)
    Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.
    Interventions:
    • Drug: Cisplatin
    • Drug: Gemcitabine Hydrochloride
    • Other: Quality-of-Life Assessment
  • Experimental: Arm IV (topotecan, cisplatin)
    Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.
    Interventions:
    • Drug: Cisplatin
    • Other: Quality-of-Life Assessment
    • Drug: Topotecan Hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
513
Not Provided
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix

    • Stage IVB, recurrent, or persistent disease
  • Not amenable to curative surgery and/or radiotherapy
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan
    • Biopsy confirmation required if lesion is less than 30 mm
    • Target lesion must be outside of a previously irradiated field
  • No craniospinal metastases
  • Performance status - GOG 0-1
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times normal
  • Alkaline phosphatase no greater than 3 times normal
  • AST no greater than 3 times normal
  • Creatinine ≤ 1.2 mg/dL
  • Creatinine > 1.2 mg/dL but < 1.5 mg/dL AND creatinine clearance ≥ 50 mL/min
  • No bilateral hydronephrosis not alleviated by ureteral stents or percutaneous drainage
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer
  • No prior malignancy whose treatment contraindicates the current study therapy
  • No concurrent clinically significant infection
  • No concurrent cytokines
  • At least 6 weeks since prior chemoradiotherapy and recovered
  • No prior chemotherapy (except when concurrently administered with radiotherapy)
  • At least 3 weeks since prior radiotherapy and recovered
  • Recovered from prior surgery
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00064077
GOG-0204, NCI-2012-02540, CDR0000306463, GOG-0204, GOG-0204, U10CA027469
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Bradley Monk Gynecologic Oncology Group
Gynecologic Oncology Group
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP