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NCT00660842 · CITED IN SOURCE DOCUMENTS

Study Comparing Weekly Versus Every 3 Week Chemotherapy in Patients With Ovarian Cancer

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
UNKNOWN
Registry last update
2023-03-24

The purpose of this study is to study efficacy and the effects on quality of life in women with ovarian cancer treated with a weekly schedule of chemotherapy with carboplatin and paclitaxel compared to those treated with standard every 3 weeks schedule of the same chemotherapy.

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.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * Cytologic or histologic diagnosis of ovarian carcinoma of the ovary, fallopian tube or primary peritoneal carcinoma, stage IC-IV * Indication for chemotherapy * Age \> 18 years * Life expectancy of at least 3 months Exclusion Criteria: * Previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix, and synchronous endometrioid carcinoma Stage Ib or less for the uterus, with ovarian tumor Stage II or higher) * Performance Status (ECOG) \> or = 3. * Previous chemotherapy * Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias) * Neutrophils \< 2000 x mm3, platelets \< 100000 x mm3 * Inadequate renal function (creatinine \> or = 1.25 x normal values) or liver function (ALT or AST \> or = 1.25 x normal values) * Present or suspected hemorrhagic syndromes * Inability to comply with protocol and follow-up * Inability to access study site for clinical visits * Refusal of informed consent
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    weekly chemotherapy
    intervention Names
    1. Drug: carboplatin
    2. Drug: paclitaxel
    label
    A
    type
    EXPERIMENTAL
  2. description
    every 3 weeks chemotherapy
    intervention Names
    1. Procedure: carboplatin
    2. Drug: paclitaxel
    label
    B
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. B
    description
    AUC 6 IV day 1 every 21 days
    name
    carboplatin
    type
    PROCEDURE
  2. arm Group Labels
    1. B
    description
    175 mg/m2 IV day 1 every 21 days
    name
    paclitaxel
    type
    DRUG
  3. arm Group Labels
    1. A
    description
    AUC 2 IV every week
    name
    carboplatin
    type
    DRUG
  4. arm Group Labels
    1. A
    description
    60mg/m2 IV every week
    name
    paclitaxel
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
800
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    quality of life
    time Frame
    weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy
  2. measure
    progression free survival
    time Frame
    every 6 months
secondary Outcomes
  1. measure
    overall survival
    time Frame
    24 months
  2. measure
    response rate
    time Frame
    after 9 and 18 weeks of therapy
  3. measure
    toxicity
    time Frame
    weekly during therapy
  4. measure
    describe the frequency and duration of symptoms in 12 months preceding ovarian cancer diagnosis
    time Frame
    at study entry
  5. measure
    describe time intervals of prediagnostic sentinel events (onset of persistent symptoms, first physician visit, diagnosis of ovarian cancer)
    time Frame
    at study entry
  6. measure
    describe patients' pathway to diagnosis of ovarian cancer according to modified Andersen's model of 'total patient delay'
    time Frame
    at study entry
Full study description
brief Summary
The purpose of this study is to study efficacy and the effects on quality of life in women with ovarian cancer treated with a weekly schedule of chemotherapy with carboplatin and paclitaxel compared to those treated with standard every 3 weeks schedule of the same chemotherapy.
detailed Description
The standard first-line treatment of ovarian cancer is combination chemotherapy with carboplatin and paclitaxel, given every 3 weeks. Researchers are looking at new ways of giving chemotherapy to make it more tolerable and more effective. One way is by giving the chemotherapy more often in smaller doses. This approach can be associated with fewer or less troubling side effects. Some chemotherapy drugs such as paclitaxel have been shown to also be more active when given once a week rather than once every 3 week schedule.
Source references
references
  1. citation
    Pignata S, Scambia G, Katsaros D, Gallo C, Pujade-Lauraine E, De Placido S, Bologna A, Weber B, Raspagliesi F, Panici PB, Cormio G, Sorio R, Cavazzini MG, Ferrandina G, Breda E, Murgia V, Sacco C, Cinieri S, Salutari V, Ricci C, Pisano C, Greggi S, Lauria R, Lorusso D, Marchetti C, Selvaggi L, Signoriello S, Piccirillo MC, Di Maio M, Perrone F; Multicentre Italian Trials in Ovarian cancer (MITO-7); Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens et du sein (GINECO); Mario Negri Gynecologic Oncology (MaNGO); European Network of Gynaecological Oncological Trial Groups (ENGOT-OV-10); Gynecologic Cancer InterGroup (GCIG) Investigators. Carboplatin plus paclitaxel once a week versus every 3 weeks in patients with advanced ovarian cancer (MITO-7): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2014 Apr;15(4):396-405. doi: 10.1016/S1470-2045(14)70049-X. Epub 2014 Feb 28.
    pmid
    24582486
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        sults are also noteworthy relative to other clinical trials of weekly dosing schedules. </li></ul></div></li><li>In a phase III trial (<a href="/clinicaltrials/NCT00660842">MITO-7</a> [NCT00660842]), the outcomes of 406 patients assigned to weekly paclitaxel (60 mg/m<span class="sup">2</span>) administered with weekly carboplati
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      2. context exact
        relative to other clinical trials of weekly dosing schedules. </li></ul></div></li><li>In a phase III trial (<a href="/clinicaltrials/NCT00660842">MITO-7</a> [NCT00660842]), the outcomes of 406 patients assigned to weekly paclitaxel (60 mg/m<span class="sup">2</span>) administered with weekly carboplatin (AUC, 2) were compared
        end
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        exact text
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      3. context exact
        </td> </tr> <tr> <td rowspan="2"> <strong> <a href="/clinicaltrials/NCT00660842">MITO-7</a> </strong> [<a href="#cit/section_7.27">27</a>,<a href="#cit/section_7.33">33</a>] </td>
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      source retrieved at
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      source string basis
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      source string sha256
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      source title
      Ovarian Epithelial, Fallopian Tube, and Primary Peritoneal Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Not medical advice