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NCT00002894 · CITED IN SOURCE DOCUMENTS

Platinum-based Chemotherapy With or Without Paclitaxel in Treating Patients With Relapsed 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
COMPLETED
Registry last update
2013-12-19

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of platinum-based chemotherapy with or without paclitaxel in treating patients with relapsed ovarian epithelial 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.

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

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Ovarian epithelial cancer or serous peritoneal carcinoma that has relapsed after prior chemotherapy * Progression-free interval (from end of last treatment) of at least 6 months * Measurable disease not required PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 2 times normal Renal: * Not specified Other: * No sepsis * No contraindication to chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
healthy Volunteers
false
sex
FEMALE
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    carboplatin
    type
    DRUG
  2. name
    cisplatin
    type
    DRUG
  3. name
    paclitaxel
    type
    DRUG
Study design
allocation
RANDOMIZED
primary Purpose
TREATMENT
Enrollment
count
800
type
ESTIMATED
Registered outcome plans (not posted results)
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of platinum-based chemotherapy with or without paclitaxel in treating patients with relapsed ovarian epithelial cancer.
detailed Description
OBJECTIVES: * Compare survival of patients with relapsed ovarian epithelial or peritoneal cancer treated with paclitaxel and either carboplatin or cisplatin vs conventional platinum-based chemotherapy. * Compare the quality of life and health economics of these regimens in these patients. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. * Arm I: Patients receive platinum-based chemotherapy (that is familiar to the oncologist and used routinely by the center) comprising either cisplatin or carboplatin alone or cisplatin in combination with other drugs. * Arm II: Patients receive paclitaxel IV over 3 hours followed by either carboplatin or cisplatin. Treatment for both arms continues every 3 weeks for up to 6 courses in the absence of unacceptable toxicity. Quality of life is assessed. Patients are followed at 6 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A maximum of 800 patients will be accrued for this study.
Source references
references
  1. citation
    Kushner DM, Connor JP, Sanchez F, Volk M, Schink JC, Bailey HH, Harris LS, Stewart SL, Fine J, Hartenbach EM; Wisconsin Oncology Network. Weekly docetaxel and carboplatin for recurrent ovarian and peritoneal cancer: a phase II trial. Gynecol Oncol. 2007 May;105(2):358-64. doi: 10.1016/j.ygyno.2006.12.018. Epub 2007 Jan 29.
    pmid
    17258800
    type
    BACKGROUND
  2. citation
    Pfisterer J, Ledermann JA. Management of platinum-sensitive recurrent ovarian cancer. Semin Oncol. 2006 Apr;33(2 Suppl 6):S12-6. doi: 10.1053/j.seminoncol.2006.03.012.
    pmid
    16716798
    type
    BACKGROUND
  3. citation
    Ledermann JA: Randomised trial of paclitaxel in combination with platinum chemotherapy versus platinum-based chemotherapy in the treatment of relapsed ovarian cancer (ICON4/OVAR2.2). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1794, 446, 2003.
    type
    RESULT
  4. citation
    Parmar MK, Ledermann JA, Colombo N, du Bois A, Delaloye JF, Kristensen GB, Wheeler S, Swart AM, Qian W, Torri V, Floriani I, Jayson G, Lamont A, Trope C; ICON and AGO Collaborators. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet. 2003 Jun 21;361(9375):2099-106. doi: 10.1016/s0140-6736(03)13718-x.
    pmid
    12826431
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        MRC/Arbeitsgemeinschaft Gynaekologische Onkologie (MRC/AGO) and the International Collaborative Ovarian Neoplasm (ICON) investigators (<a href="/clinicaltrials/NCT00002894">ICON4</a>), the following results were observed:[<a href="#cit/section_8.5">5</a>,<a href="#cit/section_8.14">14</a>][<a href="/Common/PopUps/popDefinition.as
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      source retrieved at
      2026-09-09T23:22:10.059252+00:00
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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