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Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC (Other)
Overall Status
Completed
CT.gov ID
NCT00022620
Collaborator
(none)
8
Locations

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have refractory or recurrent endometrial cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  • Determine the therapeutic activity of paclitaxel in patients with refractory or recurrent endometrial papillary carcinoma.

  • Determine the objective response and duration of response in patients treated with this regimen.

  • Determine the acute side effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 12 weeks.

PROJECTED ACCRUAL: Approximately 16-29 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study On Paclitaxel In Recurrent Uterine Papillary Serous Carcinoma (UPSC)
Study Start Date :
Jun 1, 2001
Actual Primary Completion Date :
Oct 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically confirmed endometrial papillary carcinoma (uterine papillary serous carcinoma)

    • Progressive or recurrent

    • Bidimensionally measurable disease

    • Platinum refractory disease, defined by one of the following:

    • Progression during platinum-based chemotherapy

    • Stable disease for at least 4 courses of platinum-based chemotherapy

    • Recurrence within 4 months of platinum-based chemotherapy

    • No brain involvement or leptomeningeal disease

    PATIENT CHARACTERISTICS:
    Age:
    • 75 and under
    Performance status:
    • WHO 0-2
    Life expectancy:
    • Not specified
    Hematopoietic:

    • Neutrophil count at least 1,500/mm3

    • Platelet count at least 100,000/mm3

    Hepatic:
    • Bilirubin no greater than 50 umol/L
    Renal:

    • BUN no greater than 8.0 mmol/L

    • Creatinine no greater than 120 umol/L

    • Creatinine clearance at least 60 mL/min

    Other:

    • Not pregnant

    • Fertile patients must use effective contraception

    • HIV negative

    • No other prior or concurrent malignancy except basal cell carcinoma of the skin

    • No active bacterial infection (e.g., urinary tract infection)

    • No uncontrolled or potentially active site of infection (e.g., fistula or abscess)

    • No psychological, familial, sociological, or geographical condition that would preclude study

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • Not specified
    Chemotherapy:

    • See Disease Characteristics

    • At least 4 weeks since prior chemotherapy

    • At least 1 prior platinum containing regimen

    • At least 50 mg/m2 per course for a maximum of 28 days for cisplatin

    • At least 5 times AUC for a maximum of 4 weeks per course for carboplatin

    • Prior non-taxane-containing chemotherapy allowed

    Endocrine therapy:
    • At least 4 weeks since prior hormonal therapy
    Radiotherapy:

    • At least 4 weeks since prior radiotherapy

    • At least 3 months since prior radiotherapy to target lesion

    • Concurrent radiotherapy allowed for bone pain provided evaluable lesions are outside of irradiation field)

    Surgery:
    • Prior surgical management of lymph nodes allowed

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Allgemeines Krankenhaus der Stadt Wien Vienna Austria A-1090
    2 Universitair Ziekenhuis Antwerpen Edegem Belgium B-2650
    3 U.Z. Gasthuisberg Leuven Belgium B-3000
    4 Ospedale Mauriziano Umberto I Torino Italy 10128
    5 Ospedale Civile Voghera (PV) Italy 27058
    6 Hospitais da Universidade de Coimbra (HUC) Coimbra Portugal 3049
    7 Hospital Universitasrio San Carlos Madrid Spain 28040
    8 Queen Elizabeth Hospital Gateshead England United Kingdom NE9 6SX

    Sponsors and Collaborators

    • European Organisation for Research and Treatment of Cancer - EORTC

    Investigators

    • Study Chair: Gerald Gitsch, MD, Allgemeines Krankenhaus - Universitatskliniken

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    European Organisation for Research and Treatment of Cancer - EORTC
    ClinicalTrials.gov Identifier:
    NCT00022620
    Other Study ID Numbers:
    • EORTC-55961
    • EORTC-55961
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Sep 24, 2012
    Last Verified:
    Sep 1, 2012
    Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC
    recurrent endometrial carcinoma
    endometrial papillary serous carcinoma
    Additional relevant MeSH terms:
    Endometrial Neoplasms
    Paclitaxel

    Study Results

    No Results Posted as of Sep 24, 2012