Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

NCT ID: NCT00170625

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30

Brief Summary

Compatibility of the topotecan therapy in combination with carboplatin.

Detailed Description

The aim of the study was to confirm the tolerability of 3-day topotecan therapy in combination with carboplatin in accordance with published data and to investigate the tolerability of continued therapy until disease progression or up to a maximum of 12 months.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Relapse 6-12 months

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.

Group Type: EXPERIMENTAL

Hycamtin

Intervention Type: DRUG

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

Relapse >12 months

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.

Group Type: EXPERIMENTAL

Hycamtin

Intervention Type: DRUG

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

Interventions

Hycamtin

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

North Eastern German Society of Gynaecological Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jalid Sehouli

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

References

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.

Reference Type: DERIVED

PMID: 19427025 (View on PubMed)

Other Identifiers

NOGGO ov7

Identifier Type: -

Identifier Source: org_study_id