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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005031 |
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 irofulven in treating patients who have persistent or recurrent refractory endometrial cancer.
Condition | Intervention | Phase |
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Endometrial Cancer |
Drug: irofulven |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Evaluation of MGI-114 in the Treatment of Recurrent or Persistent Endometrial Carcinoma |
Study Start Date: | August 2000 |
Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Assess the antitumor activity of 6-hydroxymethylacylfulvene in patients with persistent or recurrent, refractory endometrial carcinoma.
II. Determine the nature and degree of toxicity of this treatment in these patients.
OUTLINE: This is a multicenter study. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes on days 1-4. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed endometrial carcinoma refractory to curative therapy or established treatments Clinically or histologically confirmed persistent or recurrent disease Bidimensionally measurable disease (ascites or pleural effusions not considered measurable) Not eligible for higher priority GOG protocol
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No clinically uncontrolled dysrhythmia or signs of ischemia per ECG No congestive heart failure requiring medication No uncontrolled hypertension Other: No significant active infection No other prior or concurrent malignancy within the past 5 years except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No more than 1 prior chemotherapy regimen allowed (either single or combination cytotoxic drug therapy) No prior 6-hydroxymethylacylfulvene No prior chemotherapy for other malignancy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy for other malignancy Surgery: At least 3 weeks since prior surgery and recovered
Study Chair: | Russell J. Schilder, MD | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000067554, GOG-129L |
Study First Received: | April 6, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005031 History of Changes |
Health Authority: | United States: Federal Government |
recurrent endometrial carcinoma |
Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Endometrial Cancer Recurrence Carcinoma Genital Diseases, Female |
Endometrial Neoplasms Radiation-Sensitizing Agents Irofulven Uterine Neoplasms Antineoplastic Agents, Alkylating Alkylating Agents |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Pharmacologic Actions Genital Diseases, Female Endometrial Neoplasms |
Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Irofulven Uterine Neoplasms Antineoplastic Agents, Alkylating Alkylating Agents |