Skip to content
Triangle logo TriangleGet started
← Study library

NCT00064077 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2018-10-17

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Duration of Overall Survival (OS)

→

outcome · POSTED

Frequency of Response Using RECIST Version 1.0

→

outcome · POSTED

Duration of Progression-free Survival (PFS)

→

outcome · POSTED

Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)

→

outcome · POSTED

Pain, Assessed by Brief Pain Inventory

→

outcome · POSTED

Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4 hours on day 2.
    intervention Names
    1. Drug: Cisplatin
    2. Drug: Paclitaxel
    3. Other: Quality-of-Life Assessment
    label
    Arm I (paclitaxel, cisplatin)
    type
    EXPERIMENTAL
  2. description
    Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin IV over 1-4 hours on day 1.
    intervention Names
    1. Drug: Cisplatin
    2. Other: Quality-of-Life Assessment
    3. Drug: Vinorelbine Tartrate
    label
    Arm II (vinorelbine, cisplatin)
    type
    EXPERIMENTAL
  3. description
    Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin as in arm II.
    intervention Names
    1. Drug: Cisplatin
    2. Drug: Gemcitabine Hydrochloride
    3. Other: Quality-of-Life Assessment
    label
    Arm III (gemcitabine, cisplatin)
    type
    EXPERIMENTAL
  4. description
    Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in arm II.
    intervention Names
    1. Drug: Cisplatin
    2. Other: Quality-of-Life Assessment
    3. Drug: Topotecan Hydrochloride
    label
    Arm IV (topotecan, cisplatin)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I (paclitaxel, cisplatin)
    2. Arm II (vinorelbine, cisplatin)
    3. Arm III (gemcitabine, cisplatin)
    4. Arm IV (topotecan, cisplatin)
    description
    Given IV
    name
    Cisplatin
    other Names
    1. Abiplatin
    2. Blastolem
    3. Briplatin
    4. CDDP
    5. Cis-diammine-dichloroplatinum
    6. Cis-diamminedichloridoplatinum
    7. Cis-diamminedichloro Platinum (II)
    8. Cis-diamminedichloroplatinum
    9. Cis-dichloroammine Platinum (II)
    10. Cis-platinous Diamine Dichloride
    11. Cis-platinum
    12. Cis-platinum II
    type
    DRUG
  2. arm Group Labels
    1. Arm III (gemcitabine, cisplatin)
    name
    Gemcitabine Hydrochloride
    other Names
    1. dFdCyd
    2. Difluorodeoxycytidine Hydrochloride
    3. Gemzar
    4. LY-188011
    type
    DRUG
  3. arm Group Labels
    1. Arm I (paclitaxel, cisplatin)
    description
    Given IV
    name
    Paclitaxel
    other Names
    1. Anzatax
    2. Asotax
    3. Bristaxol
    4. Praxel
    5. Taxol
    6. Taxol Konzentrat
    type
    DRUG
  4. arm Group Labels
    1. Arm I (paclitaxel, cisplatin)
    2. Arm II (vinorelbine, cisplatin)
    3. Arm III (gemcitabine, cisplatin)
    4. Arm IV (topotecan, cisplatin)
    description
    Ancillary studies
    name
    Quality-of-Life Assessment
    other Names
    1. Quality of Life Assessment
    type
    OTHER
  5. arm Group Labels
    1. Arm IV (topotecan, cisplatin)
    description
    Given IV
    name
    Topotecan Hydrochloride
    other Names
    1. Hycamptamine
    2. Hycamtin
    3. SKF S-104864-A
    4. Topotecan HCl
    5. topotecan hydrochloride (oral)
    type
    DRUG
  6. arm Group Labels
    1. Arm II (vinorelbine, cisplatin)
    description
    Given IV
    name
    Vinorelbine Tartrate
    other Names
    1. Biovelbin
    2. Eunades
    3. KW-2307
    4. Navelbine
    5. Navelbine Ditartrate
    6. NVB
    7. Vinorelbine Ditartrate
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
513
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
    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)
secondary Outcomes
  1. description
    RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above.
    measure
    Frequency of Response Using RECIST Version 1.0
    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)
  2. description
    Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
    measure
    Duration of Progression-free Survival (PFS)
    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)
  3. description
    The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The score is calculated as the sum of the subscale scores if more than 80% of the FACT-Cx TOI items provide valid answers and all of the component subscales have valid scores. The score ranges 0-116 with a large score suggesting better QOL.
    measure
    Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)
    time Frame
    Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
  4. description
    Single item from the Brief Pain Inventory (BPI) assessing "worst pain" in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score.
    measure
    Pain, Assessed by Brief Pain Inventory
    time Frame
    Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
  5. description
    The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity.
    measure
    Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).
    time Frame
    Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1
Full study description
brief Summary
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.
detailed Description
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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-f3966fae163c8c9286f1
      requested nct id
      NCT00064077
      primary nct id
      NCT00064077
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      6955ea6d88f2638dea0c76acc97151b275d6a4c31db28ecdc8d9cabd729d6101
      payload sha256
      17a5e8871cd8dd0837a6ca7380fe09c13e5d1d1ede8b2983f8b435349b27fe02
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-f3966fae163c8c9286f1
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00064077
      occurrences
      1. context exact
        s with GOG performance status 2 (scale: 0, asymptomatic&#8211;4, totally bedridden). Therefore, PC was chosen as the reference arm in <a href="/clinicaltrials/NCT00064077">GOG-0204</a> (NCT00064077).</li></ul></div></li><li>GOG-0204 enrolled 513 patients and compared four cisplatin-based doublet regimens. The trial was closed e
        end
        230626
        exact text
        NCT00064077
        start
        230615
      2. context exact
        us 2 (scale: 0, asymptomatic&#8211;4, totally bedridden). Therefore, PC was chosen as the reference arm in <a href="/clinicaltrials/NCT00064077">GOG-0204</a> (NCT00064077).</li></ul></div></li><li>GOG-0204 enrolled 513 patients and compared four cisplatin-based doublet regimens. The trial was closed early because no one experim
        end
        230653
        exact text
        NCT00064077
        start
        230642
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/54c89187d215055b46.html
      source file sha256
      6955ea6d88f2638dea0c76acc97151b275d6a4c31db28ecdc8d9cabd729d6101
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:21:36.858766+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      a3232984df74a1d9a0f043dc5a178abeec22b6bc2629401b770fc7d9a7b60dfd
      source title
      Cervical Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 13, 2025
        datetime
        2025-05-13T12:00:00Z
        display
        May 13, 2025

    Preserved source evidence · Not medical advice