NCT00003732

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2 ovarian-cancer

Timeline
Completed

Started Sep 1998

Longer than P75 for phase_2 ovarian-cancer

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

August 12, 2013

Status Verified

July 1, 2002

First QC Date

November 1, 1999

Last Update Submit

August 9, 2013

Conditions

Ovarian Cancer

Keywords

stage IIB ovarian epithelial cancerstage IIC ovarian epithelial cancerstage IIIA ovarian epithelial cancerstage IIIB ovarian epithelial cancerstage IIIC ovarian epithelial cancerstage IV ovarian epithelial cancer

Outcome Measures

Primary Outcomes (3)

  • Maximum tolerated dose and dose-limiting toxicity of topotecan

  • Toxic effects

  • Antitumor activity

Interventions

carboplatinDRUG
paclitaxelDRUG
topotecan hydrochlorideDRUG

Eligibility Criteria

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

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

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet - Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

CarboplatinPaclitaxelTopotecan

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Svend Aage Engelholm, MD

    Rigshospitalet, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

September 1, 1998

Study Completion

September 1, 2005

Last Updated

August 12, 2013

Record last verified: 2002-07

Locations

DK(1)