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Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
carboplatin
paclitaxel
topotecan hydrochloride
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring stage IIB ovarian epithelial cancer, stage IIC ovarian epithelial cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed stage IIB, IIC, III, or IV ovarian epithelial cancer Measurable or evaluable lesion or microscopic residual disease after first surgery (phase II patients) No brain and/or leptomeningeal metastases by CT scan or MRI unless asymptomatic without corticosteroid therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Hemoglobin at least 9.0 g/dL WBC at least 3,500/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) unless liver metastases present Alkaline phosphatase no greater than 2 times ULN* SGOT no greater than 2 times ULN* NOTE: *No greater than 5 times ULN if liver metastases present Renal: Creatinine no greater than 1.5 times ULN Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic cardiac disease, including clinical congestive heart failure or arrhythmias requiring treatment No myocardial infarction within the past 3 months Other: No other malignancy except basal or squamous cell skin cancer or carcinoma in situ of the cervix No uncontrolled infection No complete bowel obstruction or other condition that would affect GI absorption or motility No concurrent medical condition for which treatment with platinum, taxane, or camptothecin analogues are contraindicated No other concurrent medical conditions that would preclude study No mental disease No history of allergy to platinum or taxanes, including drugs containing cremophor (e.g., cyclosporine or vitamin K) Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior camptothecin analogue No prior chemotherapy for ovarian cancer No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent hormonal therapy other than estrogen replacement Radiotherapy: No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 30 days or 5 half-lives since any prior investigational therapy No other concurrent investigational therapy No concurrent metoclopramide or cisapride

Sites / Locations

  • Rigshospitalet - Copenhagen University Hospital

Outcomes

Primary Outcome Measures

Maximum tolerated dose and dose-limiting toxicity of topotecan
Toxic effects
Antitumor activity

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
August 9, 2013
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00003732
Brief Title
Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer
Official Title
A Phase I/II Study to Determine the Maximum Tolerated Doses of Oral Topotecan, Carboplatin and Paclitaxel Administered Every 21 Days to Patients With Epithelial Ovarian Cancer Stages IIb, IIc, III and IV
Study Type
Interventional

2. Study Status

Record Verification Date
July 2002
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of topotecan combined with carboplatin and paclitaxel in treating patients who have stage II, stage III, or stage IV ovarian cancer.
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose, dose-limiting toxicity, and quantitative and qualitative toxic effects of oral topotecan combined with intravenous carboplatin and paclitaxel in patients with stage IIB, IIC, III, or IV ovarian epithelial cancer. (phase I closed to accrual 12/21/00) Evaluate the anti-tumor activity of this regimen in this patient population. OUTLINE: This is a multicenter, dose-escalation study of topotecan. Patients receive oral topotecan on days 1-5 and paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 5. Courses repeat every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Phase I: Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. (phase I closed to accrual 12/21/00) Phase II: An additional 50 patients receive up to 6 courses of treatment as in phase I at the MTD. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 80 patients (30 in phase I and 50 in phase II) will be accrued for this study. (phase I closed to accrual 12/21/00)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
stage IIB ovarian epithelial cancer, stage IIC ovarian epithelial cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride
Primary Outcome Measure Information:
Title
Maximum tolerated dose and dose-limiting toxicity of topotecan
Title
Toxic effects
Title
Antitumor activity

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage IIB, IIC, III, or IV ovarian epithelial cancer Measurable or evaluable lesion or microscopic residual disease after first surgery (phase II patients) No brain and/or leptomeningeal metastases by CT scan or MRI unless asymptomatic without corticosteroid therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Hemoglobin at least 9.0 g/dL WBC at least 3,500/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) unless liver metastases present Alkaline phosphatase no greater than 2 times ULN* SGOT no greater than 2 times ULN* NOTE: *No greater than 5 times ULN if liver metastases present Renal: Creatinine no greater than 1.5 times ULN Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic cardiac disease, including clinical congestive heart failure or arrhythmias requiring treatment No myocardial infarction within the past 3 months Other: No other malignancy except basal or squamous cell skin cancer or carcinoma in situ of the cervix No uncontrolled infection No complete bowel obstruction or other condition that would affect GI absorption or motility No concurrent medical condition for which treatment with platinum, taxane, or camptothecin analogues are contraindicated No other concurrent medical conditions that would preclude study No mental disease No history of allergy to platinum or taxanes, including drugs containing cremophor (e.g., cyclosporine or vitamin K) Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior camptothecin analogue No prior chemotherapy for ovarian cancer No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent hormonal therapy other than estrogen replacement Radiotherapy: No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 30 days or 5 half-lives since any prior investigational therapy No other concurrent investigational therapy No concurrent metoclopramide or cisapride
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svend Aage Engelholm, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Rigshospitalet - Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer

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