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Etoposide in Treating Patients With Advanced Ovarian or Cervical Cancer

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00002478
First received: November 1, 1999
Last updated: June 7, 2013
Last verified: November 2000

November 1, 1999
June 7, 2013
June 1993
October 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00002478 on ClinicalTrials.gov Archive Site
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Etoposide in Treating Patients With Advanced Ovarian or Cervical Cancer
Phase II Study of Prolonged Oral VP-16 for Advanced Ovarian Epithelial and Cervical Cancer

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 etoposide in treating patients who have refractory, recurrent, or metastatic ovarian or cervical cancer.

OBJECTIVES: I. Determine the efficacy of prolonged oral etoposide (VP-16) in patients with advanced ovarian epithelial or cervical cancer. II. Evaluate the frequency and severity of observed adverse effects in this patient population treated with prolonged oral VP-16.

OUTLINE: Patients receive etoposide by mouth once daily on days 1-21 every 4 weeks. Patients with responding disease continue treatment for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients with stable disease continue treatment for up to 6 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: If 4-6 responses are observed in the first 25 patients, an additional 15 patients will be entered. The estimated duration of the study is 8 months.

Interventional
Phase 2
Primary Purpose: Treatment
  • Cervical Cancer
  • Ovarian Cancer
Drug: etoposide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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October 2003   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or metastatic ovarian epithelial or cervical cancer Tissue not accessible for biopsy Refractory to curative therapy or established treatments and ineligible for higher priority GOG protocols Measurable disease required, as follows: Lesion measurable by physical exam Lesion bidimensionally measurable on sonogram or imaging Ascites/pleural effusion not measurable

PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelets at least 100,000/mm3 Hepatic: Bilirubin no more than 1.5 times normal AST no more than 3 times normal Alkaline phosphatase no more than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Other: Body surface area at least 1 square meter No requirement for intravenous hydration or nutritional support No significant infection No second malignancy other than nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since anticancer therapy Chemotherapy: No more than 1 prior chemotherapy trial No prior etoposide At least 3 weeks since chemotherapy and recovered Endocrine therapy: At least 3 weeks since anticancer therapy Radiotherapy: At least 3 weeks since radiotherapy Surgery: At least 3 weeks since surgery and recovered

Female
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002478
CDR0000077078, GOG-26LL
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Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Peter G. Rose, MD University Hospitals Seidman Cancer Center
Gynecologic Oncology Group
November 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP