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Phase I Trial of the Treatment of Advanced Endometrial Cancer With Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy


Phase 1
18 Years
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

Phase I Trial of the Treatment of Advanced Endometrial Cancer With Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

D. Scott McMeekin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oklahoma University Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000067856

NCT ID:

NCT00005840

Start Date:

July 2000

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • endometrial papillary serous carcinoma
  • endometrial clear cell carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
University of Chicago Cancer Research Center Chicago, Illinois  60637
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University Cleveland, Ohio  44106
Lake/University Ireland Cancer Center Mentor, Ohio  44060
Oklahoma University Medical Center Oklahoma City, Oklahoma  73104
Cancer Care Associates - Midtown Tulsa Tulsa, Oklahoma  74104
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195