Know Cancer

or
forgot password

Phase II Study On Paclitaxel In Recurrent Uterine Papillary Serous Carcinoma (UPSC)


Phase 2
N/A
75 Years
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

Phase II Study On Paclitaxel In Recurrent Uterine Papillary Serous Carcinoma (UPSC)


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Gerald Gitsch, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Allgemeines Krankenhaus - Universitatskliniken

Authority:

United States: Federal Government

Study ID:

EORTC-55961

NCT ID:

NCT00022620

Start Date:

June 2001

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • recurrent endometrial carcinoma
  • endometrial papillary serous carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Cystadenocarcinoma, Serous
  • Adenoma

Name

Location