Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have refractory or recurrent endometrial cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study On Paclitaxel In Recurrent Uterine Papillary Serous Carcinoma (UPSC) |
| Study Start Date: | June 2001 |
| Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Austria | |
| Allgemeines Krankenhaus der Stadt Wien | |
| Vienna, Austria, A-1090 | |
| Belgium | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Italy | |
| Ospedale Mauriziano Umberto I | |
| Torino, Italy, 10128 | |
| Ospedale Civile | |
| Voghera (PV), Italy, 27058 | |
| Portugal | |
| Hospitais da Universidade de Coimbra (HUC) | |
| Coimbra, Portugal, 3049 | |
| Spain | |
| Hospital Universitasrio San Carlos | |
| Madrid, Spain, 28040 | |
| United Kingdom | |
| Queen Elizabeth Hospital | |
| Gateshead, England, United Kingdom, NE9 6SX | |
| Study Chair: | Gerald Gitsch, MD | Allgemeines Krankenhaus - Universitatskliniken |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00022620 History of Changes |
| Other Study ID Numbers: | EORTC-55961, EORTC-55961 |
| Study First Received: | August 10, 2001 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
recurrent endometrial carcinoma endometrial papillary serous carcinoma |
Additional relevant MeSH terms:
|
Cystadenocarcinoma, Serous Cystadenocarcinoma Endometrial Neoplasms Sarcoma, Endometrial Stromal Adenoma 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 Endometrial Stromal Tumors Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Cystic, Mucinous, and Serous Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013