NCT00014690

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2001

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 26, 2004

Completed
Last Updated

August 2, 2013

Status Verified

December 1, 2004

First QC Date

April 10, 2001

Last Update Submit

August 1, 2013

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancerfallopian tube cancerprimary peritoneal cavity cancer

Interventions

plevitrexedDRUG
topotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

AstraZeneca Pharmaceuticals LP

Wilmington, Delaware, 19850-5437, United States

Location

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

ZD 9331Topotecan

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Bernadette Matthews, RN, MSN, CCRA

    AstraZeneca

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 10, 2001

First Posted

February 26, 2004

Study Start

March 1, 2001

Study Completion

February 1, 2004

Last Updated

August 2, 2013

Record last verified: 2004-12

Locations

US(1)