Hycamtin Plus Carboplatin Versus Established Regimens for the Treatment of Ovarian Cancer Relapse

NCT00437307 | Completed Phase 3

• 1 other identifier: 3104000
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

Determination of progression free survival after 12 months of FU Determination of total survival, response and quality of life

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  after 1 year-follow-up

Secondary Outcomes (1)

• overall survival, efficacy and tolerability of the regimes and quality of life

  during study and follow-up

Study Arms (2)

1

ACTIVE COMPARATOR

Topotecan: 0,75 mg/m²/d, Tage 1-3 und Carboplatin: AUC 5 (after Cockroft and Gault formula) am Tag 3 nach Topotecan, q 21d.

Drug: Topotecan

2

NO INTERVENTION

Paclitaxel 175 mg/m2/d, day 1 and Carboplatin: AUC 5 (after Cockroft and Gault formula), day 1, q21d OR gemcitabine 1000 mg/m2/d, day 1 and 8 and Carboplatin AUC 4 (after Cockroft and Gault formula), day 1, q 21d.

Interventions

Topotecan DRUG

Topotecan: 0,75 mg/m²/d, day 1-3, and Carboplatin: AUC 5 (after Cockroft and Gault Formula) on day 3 after Topotecan, q 21d

Also known as: Hycamtin

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ≥18 years of age with platinum-sensitive recurrent ovarian cancer occurring at least six months after completion of primary standard therapy are eligible
• Patients with measurable or assessable lesions or CA-125 ≥ 2x ULN an Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2
• All patients will provide written informed consent

You may not qualify if:

• Patients with more than two chemotherapies in their history
• Progress less than six months after completion of primary standard therapy
• Simultaneous or planned radiation
• Any known hypersensitivity to topotecan, carboplatin, paclitaxel or gemcitabine
• Patients with infection
• Patients who are pregnant or breast feeding

Sponsors & Collaborators

• North Eastern German Society of Gynaecological Oncology: lead

Study Sites (1)

Charité Campus Virchow Klinikum

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Jalid Sehouli

  Charité Campus Vichow Klinikum

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2007
• First Posted: February 21, 2007
• Study Start: March 1, 2007
• Primary Completion: July 1, 2013
• Study Completion: June 1, 2015
• Last Updated: September 22, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)