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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
This study has been completed.
Study NCT00005840   Information provided by National Cancer Institute (NCI)
First Received: June 2, 2000   Last Updated: October 16, 2009   History of Changes

June 2, 2000
October 16, 2009
July 2000
July 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00005840 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
Phase I Trial of the Treatment of Advanced Endometrial Cancer With Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of combination chemotherapy when given with radiation therapy in treating patients with stage III or stage IV endometrial cancer.

OBJECTIVES:

  • Determine the safety and maximum tolerated doses of paclitaxel and cisplatin when administered with radiotherapy in patients with stage III or IV endometrial cancer.
  • Assess the time to disease progression and overall survival of patients treated with this regimen.

OUTLINE: This is a dose-escalation study of paclitaxel and cisplatin.

Patients receive paclitaxel IV over 1 hour and cisplatin IV on days 1, 8, 15, 22, 29, and 36. Patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks.

Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 3-48 patients will be accrued for part I and 14-20 patients will be accrued for part II of this study.

Phase I
Interventional
Treatment
Endometrial Cancer
  • Drug: cisplatin
  • Drug: paclitaxel
  • Procedure: adjuvant therapy
  • Radiation: radiation therapy
 
McMeekin DS, Walker JL, Hartenbach EM, Bookman MA, Koh WJ. Phase I trial of the treatment of high-risk endometrial cancer with concurrent weekly paclitaxel and cisplatin and whole abdominal radiation therapy: A Gynecologic Oncology Group study. Gynecol Oncol. 2008 Oct 27; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
July 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed surgical stage III or IV endometrial cancer OR
  • Any stage clear or serous papillary endometrial cancer
  • Positive para-aortic lymph nodes allowed
  • Tumor must be surgically reduced to 2 cm or less within 8 weeks of study

    • Must have had hysterectomy and bilateral salpingo-oophorectomy
  • No recurrent disease
  • No metastases to lung or liver parenchyma or inguinal or scalene lymph nodes

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 2,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT no greater than 3 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Other:

  • No other prior or concurrent malignancy in the past 5 years except non-melanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics
  • No more than 8 weeks since prior surgery

Other:

  • No prior anticancer therapy that would preclude study
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005840
 
CDR0000067856, GOG-9907
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: D. Scott McMeekin, MD Oklahoma University Cancer Institute
National Cancer Institute (NCI)
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP