Liposome-Encapsulated Doxorubicin Citrate With or Without Gemcitabine Hydrochloride in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer

NCT01100372 | Unknown Phase 2

• 4 other identifiers: CDR0000669716MUI-AGO-10EUDRACT-2008-008746-20EU-21028
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated doxorubicin citrate and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether liposome-encapsulated doxorubicin citrate is more effective when given together with or without gemcitabine hydrochloride in killing tumor cells. PURPOSE: This randomized phase II trial is studying liposome-encapsulated doxorubicin citrate given together with gemcitabine hydrochloride to see how well it works compared with liposome-encapsulated doxorubicin citrate alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; recurrent fallopian tube cancer; recurrent primary peritoneal cavity cancer

Outcome Measures

Primary Outcomes (1)

• Remission rates (complete response and partial response)

Secondary Outcomes (4)

• Quality of life as measured by EORTC-QLQ30 and QLQ-OV28 questionnaires

• Progression-free survival

• Overall survival

• Toxicity

Interventions

gemcitabine hydrochloride DRUG

liposome-encapsulated doxorubicin citrate DRUG

quality-of-life assessment PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer * Progression or recurrence during first-line platinum-based chemotherapy (platinum-refractory disease) OR progression or recurrence during the first 6 months following the end of the last platinum-containing chemotherapy (platinum-resistant disease) * Meets ≥ 1 of the following criteria: * Measurable metastatic disease on CT or MRI scan, ultrasound, or chest x-ray * Evaluable disease on CT/MRI scan (e.g., ascites or pleural effusion) or chest x-ray (e.g., pleural effusion) * Tumor marker progression (CA-125) according to Rustin criteria, meeting 1 of the following criteria: * CA-125 \> 2 times upper limit of normal (UNL) * CA-125 \> 2 times nadir value on two occasions * No ovarian carcinosarcoma (malignant mixed Müllerian tumor) or pure sarcoma PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Life expectancy ≥ 3 months * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 g/dL * Neutrophil count ≥ 1.5 x 10³/mm³ * Serum creatinine \< 1.5 times ULN * Bilirubin \< 1.5 times ULN (\< 2.5 times ULN if liver metastases are present) * AST/ALT \< 2.5 times ULN (unless caused by parenchymal liver metastases) * No childbearing capacity * LVEF ≥ 50% by ECHO or MUGA scan * No significant comorbidity (e.g., uncontrolled infection, clinical signs of cardiac insufficiency, history of myocardial infarction, or cardiac rhythmic disorders \[NYHA class III-IV disease\]) * No known hypersensitivity to study drugs * No active secondary malignant tumor within the past 5 years (e.g., metastases from primary breast cancer) * No condition (medical, social, or psychological), that would prevent adequate follow-up PRIOR CONCURRENT THERAPY: * No prior chemotherapy with pegylated liposomal doxorubicin hydrochloride, other anthracyclines, or gemcitabine hydrochloride * No other concurrent tumor-specific therapy for ovarian cancer

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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Innsbruck Universitaetsklinik

Innsbruck, A-6020, Austria

RECRUITING

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Gemcitabine

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)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Alain Zeimet

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: April 8, 2010
• Study Start: July 1, 2009
• Primary Completion: May 1, 2014
• Last Updated: August 26, 2013

Record last verified: 2010-04

Locations

AU (1)