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Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer

This study is currently recruiting participants.
Verified August 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00942357
First received: July 17, 2009
Last updated: August 10, 2012
Last verified: August 2012
History of Changes
  Purpose

RATIONALE: Drugs used in chemotherapy, such as carboplatin, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether carboplatin and paclitaxel are more effective with or without cisplatin and radiation therapy in treating patients with endometrial cancer.

PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel to see how well they work when given with or without cisplatin and radiation therapy in treating patients with stage I, stage II, stage III, or stage IVA endometrial cancer.


Condition Intervention Phase
Endometrial Cancer
 Drug: carboplatin
Drug: cisplatin
Drug: paclitaxel
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Recurrence-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Cumulative incidence of local recurrence [ Designated as safety issue: No ]
  • Cumulative incidence of distant metastases [ Designated as safety issue: No ]
  • Acute and late adverse effects as measured by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Patient-reported quality of life [ Designated as safety issue: No ]

Estimated Enrollment: 804
Study Start Date: June 2009
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive cisplatin IV on days 1 and 29. Patients also undergo external-beam radiotherapy once daily, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
 Drug: carboplatin
Given IV
Drug: cisplatin
Given IV
Drug: paclitaxel
Given IV
Experimental: Arm II
Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
 Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV

Detailed Description:

OBJECTIVES:

Primary

  • Compare the recurrence-free survival of patients with stage I-IVA endometrial carcinoma treated with adjuvant chemoradiotherapy comprising cisplatin and tumor volume-directed radiotherapy followed by carboplatin and paclitaxel vs carboplatin and paclitaxel alone.

Secondary

  • Compare the overall survival of patients treated with these regimens.
  • Compare the acute and late adverse effects of these regimens in these patients.
  • Determine the impact of these regimens on patient-reported quality of life during and for up to 1 year after completion of study treatment.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive cisplatin IV on days 1 and 29. Patients also undergo external-beam radiotherapy once daily, 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients complete quality-of-life questionnaires at baseline and periodically during study using the FACT-G Physical and Functional Well-Being, FACT-Endometrial, FACT/GOG Neuropathy, and FACT-C (items C3 and C5).

After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed endometrial carcinoma, including the following cell types:

    • Clear cell carcinoma
    • Serous papillary carcinoma
    • Undifferentiated carcinoma

  • Surgical stage III or IVA disease per FIGO 2009 staging criteria

    • Surgical stage III disease includes positive adnexa, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement
    • Surgical stage IVA disease includes bladder or bowel mucosal involvement, but no spread outside the pelvis
  • Surgical stage I or II endometrial clear cell or serous papillary carcinoma with positive peritoneal cytology per FIGO 2009 staging criteria

  • Has undergone optimal surgical debulking that included a hysterectomy and bilateral salpingo-oophorectomy within the past 8 weeks

    • Residual tumor after surgery (any single site) ≤ 2 cm in maximum dimension
  • No carcinosarcoma
  • No parenchymal liver metastases
  • No recurrent endometrial cancer or endometrioid stage I or II with positive peritoneal cytology

PATIENT CHARACTERISTICS:

  • GOG performance status 0-2
  • Life expectancy ≥ 3 months
  • WBC ≥ 3,000/mm^3
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ 1.5 times ULN
  • Creatinine ≤ ULN
  • No myocardial infarction, unstable angina, or uncontrolled arrhythmia within the past 3 months
  • No other active invasive malignancy within the past 5 years except for non-melanoma skin cancer
  • No history of serious co-morbid or uncontrolled illness that would preclude study therapy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior pelvic or abdominal radiotherapy
  • No prior chemotherapy for endometrial cancer
  • No prior cancer treatment that would preclude study therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942357

  Show 355 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Daniela E. Matei, MD Indiana University Melvin and Bren Simon Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00942357     History of Changes
Other Study ID Numbers: CDR0000649079, GOG-0258
Study First Received: July 17, 2009
Last Updated: August 10, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
endometrial clear cell carcinoma
endometrial papillary serous carcinoma
stage IA endometrial carcinoma
stage IB endometrial carcinoma
stage II endometrial carcinoma
 stage IIIA endometrial carcinoma
stage IIIB endometrial carcinoma
stage IIIC endometrial carcinoma
stage IVA endometrial carcinoma
stage IVB endometrial carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Adenoma
Endometrial Stromal Tumors
Cisplatin
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
 Neoplasms, Connective and Soft Tissue
Neoplasms, Glandular and Epithelial
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 19, 2013