Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

NCT00031954 | Completed Phase 2

• 3 other identifiers: AGO-OVAR 8AGOSG-OVAR-8EU-20146
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 18

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IC, stage IIB, stage III, or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer that has not been previously treated.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

stage II ovarian epithelial cancer; stage I ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; fallopian tube cancer; primary peritoneal cavity cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of tolerability and toxicity of the combination therapy with paclitaxel, carboplatin and gemcitabine (P-C-G) in first line treatment of ovarian cancer patients. Evaluation of Drop-out rate due to toxicity

  The decision level is reached, when the lower exact 95% confidence limit of the observed proportion is higher than the upper exact 95% confidence limit of the historical proportion, which corresponds to a power of 0.5 applying a significance level of 0.05

  Based on decision level

Interventions

carboplatin DRUG

gemcitabine hydrochloride DRUG

paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed stage IC-IV ovarian epithelial, fallopian tube, or peritoneal carcinoma * No tumors of low-malignant potential (borderline tumors) * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 OR * Karnofsky 70-100% Life expectancy: * At least 6 months Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin greater than 10 g/dL Hepatic: * Bilirubin no greater than 2 times upper limit of normal Renal: * Glomerular filtration rate at least 60 mL/min Cardiovascular: * No history of congestive heart failure (New York Heart Association class III or IV heart disease) even if medically controlled * No myocardial infarction within the past 6 months * No history of atrial or ventricular arrhythmias Neurologic: * No history of seizure disorder * No history of CNS disorder * No pre-existing motor or sensory neuropathy or symptoms grade 2 or greater Other: * No severe concurrent infection * No prior hypersensitivity reaction to products containing Cremophor EL or compounds chemically related to carboplatin, paclitaxel, or gemcitabine * No complete bowel obstruction * No other concurrent severe medical problems that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy * No concurrent WBC transfusions Chemotherapy: * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy except replacement therapy or steroid antiemetics Radiotherapy: * No prior radiotherapy * No concurrent radiotherapy Surgery: * No more than 6 weeks since prior definitive surgery

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

Sponsors & Collaborators

• AGO Study Group: lead

Study Sites (18)

Universitaetsklinikum Charite

Berlin, D-10117, Germany

Location

Zentralkrankenhaus

Bremen, D-28205, Germany

Location

Medizinische Klinik I

Dresden, D-01307, Germany

Location

Evangelisches Krankenhaus

Düsseldorf, DOH-4-0217, Germany

Location

Klinikum der J.W. Goethe Universitaet

Frankfurt, D-60590, Germany

Location

Staedtisches Krankenhaus FFM-Hoechst

Frankfurt am Main, 65929, Germany

Location

Universitaetsklinik Goettingen

Göttingen, D-37075, Germany

Location

Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet

Greifswald, D-17487, Germany

Location

Frauenklinik der MHH

Hanover, 30659, Germany

Location

Vincentius Krankenhaus

Karlsruhe, D-76137, Germany

Location

Christian-Albrechts University of Kiel

Kiel, D-24105, Germany

Location

Klinik der Otto-v.-Guericke-Universitat

Magdeburg, 39108, Germany

Location

Klinikum Grosshadern

Munich (Muenchen), D-81377, Germany

Location

Klinikum Rechts Der Isar/Technische Universitaet Muenchen

Munich (Muenchen), D-81675, Germany

Location

Klinik und Poliklinik fuer Kinderheilkunde

Münster, D-48129, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, D-72076, Germany

Location

Universitaet Ulm

Ulm, D-89075, Germany

Location

Dr. Horst-Schmidt-Kliniken

Wiesbaden, D-65199, Germany

Location

Related Publications (1)

• du Bois A, Belau A, Wagner U, Pfisterer J, Schmalfeldt B, Richter B, Staehle A, Jackisch C, Lueck HJ, Schroeder W, Burges A, Olbricht S, Elser G; Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group (AGO-OVAR). A phase II study of paclitaxel, carboplatin, and gemcitabine in previously untreated patients with epithelial ovarian cancer FIGO stage IC-IV (AGO-OVAR protocol OVAR-8). Gynecol Oncol. 2005 Feb;96(2):444-51. doi: 10.1016/j.ygyno.2004.10.020.

  PMID: 15661234 RESULT

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Carboplatin; Gemcitabine; Paclitaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Andreas du Bois, MD, PhD

  Dr. Horst-Schmidt-Kliniken

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2002
• First Posted: July 1, 2003
• Study Start: August 1, 2001
• Primary Completion: April 1, 2004
• Last Updated: December 23, 2015

Record last verified: 2015-12

Locations

DE (18)