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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 CenterSeattle, Washington  98109
University of Chicago Cancer Research CenterChicago, Illinois  60637
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve UniversityCleveland, Ohio  44106
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Cancer Care Associates - Midtown TulsaTulsa, Oklahoma  74104
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195