ZD9331 With or Without Topotecan in Treating Patients With Refractory or Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

August 1, 2013 updated by: AstraZeneca

A Phase II, Open, Randomized Multicenter Trial to Assess the Efficacy and Tolerability of Intravenous ZD9331 Given as Monotherapy (at Two Doses) or in Combination With Topotecan, in Patients With Ovarian Cancer Refractory or Recurrent After Failing Platinum and Paclitaxel in Combination

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining two or more drugs may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of different regimens of ZD9331 with or without topotecan in treating patients who have refractory or recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Compare the efficacy of ZD9331 with or without topotecan in patients with refractory or recurrent ovarian epithelial, primary peritoneal, or fallopian tube cancer. II. Compare the tolerability of these regimens in these patients. III. Compare the objective tumor response rate, progression-free survival, and disease control in patients treated with these regimens. IV. Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 3 treatment arms. Arm I: Patients receive ZD9331 IV over 30 minutes on days 1 and 8. Arm II: Patients receive a higher dose of ZD9331 IV over 30 minutes on days 1 and 8. Arm III: Patients receive ZD9331 as in arm I and topotecan IV over 30 minutes on days 1-5. All arms: Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, on the first day of each course, and then at study withdrawal. Patients are followed at day 30, every 9 weeks until disease progression, and then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 130 patients will be accrued for this study within 5 months.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19850-5437
        • AstraZeneca Pharmaceuticals LP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer Refractory or recurrent disease after combination platinum and paclitaxel as only prior chemotherapy regimen Platinum resistant (i.e., refractory or relapsed within 6 months after completion of last therapy regimen) No more than 2 prior platinum and paclitaxel combination regimens Measurable disease No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: More than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: No unstable or uncompensated hepatic disease Bilirubin less than 1.25 times upper limit of normal (ULN) Albumin at least lower limit of normal ALT or AST no greater than 2.5 times ULN (5 times ULN if liver metastases present) Renal: No unstable or uncompensated renal disease Creatinine clearance at least 60 mL/min Cardiovascular: No unstable or uncompensated cardiac disease Pulmonary: No unstable or uncompensated respiratory disease Other: No concurrent intestinal obstruction No evidence of severe or uncontrolled systemic disease No other active malignancy within the past 5 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix No severe concurrent condition that would preclude study compliance No risk of transmitting HIV or hepatitis B or C Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No prior extensive radiotherapy to more than 30% of bone marrow (e.g., whole pelvis or half of spine) No concurrent radiotherapy for ovarian cancer Surgery: At least 2 weeks since prior surgery,except for insertion of central venous access device, and recovered Other: At least 4 weeks since other anticancer therapy and recovered Concurrent folic acid in a nutritional supplement allowed except within the 24 hours before and after ZD9331 dosing No other concurrent study drugs No other concurrent systemic therapy for ovarian cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Chair: Bernadette Matthews, RN, MSN, CCRA, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

April 10, 2001

First Submitted That Met QC Criteria

February 25, 2004

First Posted (Estimate)

February 26, 2004

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

December 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZENECA-9331IL/0024
  • CDR0000068604 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancer

Clinical Trials on topotecan hydrochloride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe