Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Carcinoma

NCT00429559 | Completed Phase 1

• 1 other identifier: CT/06.14
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 6

Brief Summary

Topotecan and gemcitabine are drugs globally registered for recurrent ovarian carcinoma. This trial will determine the maximum tolerated dose and the efficacy of this combination administered weekly in patients with platinum -resistant ovarian cancer.

Conditions

Ovarian Cancer

Keywords

Cancer;; Ovarian cancer;; Recurrent ovarian cancer platinum-resistant

Outcome Measures

Primary Outcomes (1)

• Determine the maximum tolerated dose and the response rate of gemcitabine plus topotecan.

  1year

Secondary Outcomes (1)

• Toxicity profile

  1 year

Study Arms (1)

A

EXPERIMENTAL

Drug: Hycamptin; Drug: Gemcitabine

Interventions

Hycamptin DRUG

1.75mg/m2 IV on day 1 every week for 3 weeks in cycles of 4 weeks Number of cycles: until progression

Also known as: Topotecan

A

Gemcitabine DRUG

Gemcitabine at starting dose of 700 mg/m 2 with increments of 100 mg/m2 IV on day 1 every week for 3 weeks in cycles of four weeks. Number of cycles: until progression

Also known as: Gemzar

A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed ovarian adenocarcinoma
• Patients had to have received a front-line, platinum- based chemotherapy regimen
• Patients who progressed or whose best response to their most recent platinum-based therapy was less than a partial response will be classified as having platinum-refractory/resistant ovarian cancer. This category also will include patients with disease progression within six months of completing the most recent platinum-based chemotherapy
• Patients had to have at least one bidimensionally measurable and/or evaluable (unidimensionally measurable) target lesion in a non-irradiated area, or increased Ca 125
• A \>= 4 weeks interval between their last chemotherapy regimen and the start of study treatment
• Age \> 18 years old
• Performance status (WHO) 0-2
• Life expectancy of at least three months
• Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3)
• Adequate liver (bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2 mg/dl)
• Informed consent

You may not qualify if:

• Pregnant or nursing
• Psychiatric illness or social situation that would preclude study compliance
• Other concurrent uncontrolled illness
• Other invasive malignancy within the past 5 years except nonmelanoma skin cancer

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (6)

University Hospital of Crete

Heraklion, Crete, 71110, Greece

Location

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athnes, Dep of Medical Oncology

Athens, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

State General Hospital of Larissa, Dep of Medical Oncology

Larissa, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms

Interventions

Topotecan; Gemcitabine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; 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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Antonia Kalikaki, MD

  University Hospital of Crete, Dep of Medical Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 30, 2007
• First Posted: January 31, 2007
• Study Start: June 1, 2006
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 22, 2011

Record last verified: 2011-07

Locations

GR (6)