NCT00170625

Brief Summary

Compatibility of the topotecan therapy in combination with carboplatin.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 ovarian-cancer

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

June 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
11.4 years until next milestone

Results Posted

Study results publicly available

February 6, 2017

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

September 9, 2005

Results QC Date

October 4, 2016

Last Update Submit

November 7, 2024

Conditions

Ovarian Cancer

Keywords

platin-resistant

Outcome Measures

Primary Outcomes (1)

  • Occurrence of a DLT (Dose Limiting Toxicity)

    A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.

    after each cycle for up to one year

Secondary Outcomes (1)

  • Progression-free Survival (PFS)

    after every third cycle, for up to one year

Study Arms (2)

Relapse 6-12 months

EXPERIMENTAL

dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application) If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)) A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.

Drug: Hycamtin

Relapse >12 months

EXPERIMENTAL

dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application) If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)) A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.

Drug: Hycamtin

Interventions

HycamtinDRUG

Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d

Relapse 6-12 monthsRelapse >12 months

Eligibility Criteria

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

You may qualify if:

  • Age \>= 18 years
  • patient with ovarian cancer after primary therapy
  • bone marrow function leukocytes \>= 4,0 x 109/ l, platelets \>= 100 109/l, hemoglobin \>= 9 g/dl
  • renal function creatinin \<= 1,5 mg% or creatinin clearance \>= 60 ml/min
  • liver function bilirubin \<= 2,0 mg/dl, SGOT, SGPT and AP within 3 fold of the reference laboratory's normal range
  • ECOG \<= 2
  • Intention of regular follow-up visits for the duration of the study
  • written informed consent

You may not qualify if:

  • any known hypersensitivity against topotecan isomerase-I-inhibitor other medication included in the study protocol
  • ECOG \> 2
  • patients with radiotherapy within the last 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fotopoulou C, Karavas A, Trappe R, Chekerov R, Lichtenegger W, Sehouli J. Venous thromboembolism in recurrent ovarian cancer-patients: A systematic evaluation of the North-Eastern German Society of Gynaecologic Oncology Ovarian Cancer Study Group (NOGGO). Thromb Res. 2009 Nov;124(5):531-5. doi: 10.1016/j.thromres.2009.03.013. Epub 2009 May 8.

    PMID: 19427025DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Topotecan

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 Disorders

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Results Point of Contact

Title
Prof. Dr. Jalid Sehouli
Organization
Charite Campus Vichow Klinikum
jalid.sehouli@charite.de
+49 30-450564052

Study Officials

  • Jalid Sehouli

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

June 1, 2004

Primary Completion

August 1, 2005

Last Updated

November 12, 2024

Results First Posted

February 6, 2017

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share