Trial record 19 of 141 for:    Open Studies | "Peritoneal Diseases"

A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Janssen Research & Development, LLC
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01846611
First received: May 1, 2013
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to assess the efficacy and safety of trabectedin+DOXIL as a third-line chemotherapy regimen (treatment) in patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who received 2 previous lines of platinum-based chemotherapy.


Condition Intervention Phase
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Drug: Trabectedin
Drug: DOXIL
Drug: Dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Up to 2 months after the last participant has received the last dose of study medication or when 514 deaths have been observed, whichever is later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: Up to the date of disease progression or death measured up to 2 months after the last participant has received the last dose of study medication or when 514 deaths have been ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: Up to 2 months after the last participant has received the last dose of study medication or when 514 deaths have been observed, whichever is later ] [ Designated as safety issue: No ]
  • Area under the concentration curve of trabectedin as derived from sparse population pharmacokinetics [ Time Frame: Predose Day 1, 1 hour after start of study dose infusion, 10 minutes before the end of study dose infusion, and 0.5, 24, and 168 hours after the end of study dose infusion on Cycle 1 only ] [ Designated as safety issue: No ]
  • Minimum observed plasma concentration of trabectedin as derived from sparse population pharmacokinetics [ Time Frame: Predose Day 1, 1 hour after start of study dose infusion, 10 minutes before the end of study dose infusion, and 0.5, 24, and 168 hours after the end of study dose infusion on Cycle 1 only ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration of trabectedin as derived from sparse population pharmacokinetics [ Time Frame: Predose Day 1, 1 hour after start of study dose infusion, 10 minutes before the end of study dose infusion, and 0.5, 24, and 168 hours after the end of study dose infusion on Cycle 1 only ] [ Designated as safety issue: No ]
  • Number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last participant has received the last dose of study medication ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 670
Study Start Date: October 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: trabectedin + DOXIL Drug: Trabectedin
1.1 mg/m2 administered intravenously over 3 hours on Day 1 of each 21-day treatment cycle
Drug: DOXIL
30 mg/m2 administered intravenously over 90 minutes on Day 1 of each 21-day treatment cycle
Drug: Dexamethasone
20 mg administered intravenously on Day 1 of each 21-day treatment cycle approximately 30 minutes prior to study drug infusion
Active Comparator: Arm B: DOXIL Drug: DOXIL
50 mg/m2 administered intravenously over 90 minutes on Day 1 of each 28-day treatment cycle

Detailed Description:

This is a randomized (individuals assigned to study treatment by chance), open-label (identity of assigned study drug will be known), active-controlled study in adult female patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who received 2 previous lines of platinum-based chemotherapy. Approximately 670 participants will be enrolled. Patients will be stratified by 4 criteria defined in the protocol and randomly assigned in a 1:1 ratio to the trabectedin+DOXIL combination therapy group (Arm A) or to the DOXIL (pegylated liposomal doxorubicin) monotherapy group (Arm B). During the treatment phase, patients will receive study drug infusions according to 21-day cycles in Arm A and 28-day cycles in Arm B. Treatment will continue until the occurrence of disease progression or unacceptable treatment toxicity, or until 2 cycles beyond a confirmed complete response is documented. Up to 2 additional cycles of study drug are allowed after complete response, at the discretion of the principal investigator. Efficacy assessments will be evaluated using Response Evaluation Criteria in Solid Tumors. Disease assessments, including assessments for patients who discontinue treatment for reasons other than disease progression, will be performed until disease progression, the start of subsequent anticancer therapy, withdrawal of consent, or the clinical cutoff date. Collection of survival status will continue until at least 514 deaths have been observed. Serial pharmacokinetic (PK) samples will be collected in a subset of patients who voluntarily consent to the PK portion of the study. Safety will be monitored throughout the study. An interim analysis of overall survival (OS) will be performed after approximately 308 participants have died. The final analysis of OS will occur when approximately 514 deaths have been observed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
  • Received first-line treatment with a platinum-based regimen and had no evidence of disease progression for 6 months after the last dose
  • Received second-line treatment with a platinum-based regimen, with progression of disease after attaining a complete response (CR) or partial response (PR)
  • Progression of disease based on imaging after the second-line platinum-based regimen (individuals treated with a pegylated liposomal doxorubicin-containing regimen as a second-line therapy are eligible if subsequent disease progression occurs >=9 months from the first dose)
  • Evidence of measurable disease at screening as evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
  • Able to receive intravenous (IV) dexamethasone or an equivalent IV corticosteroid
  • Have a known BRCA 1/2 mutation status (for participants who do not have a known BRCA 1/2 status at screening, a blood sample will be collected to determine the status with the results available prior to randomization
  • Laboratory values within protocol -defined parameters
  • Have left ventricular ejection fraction by multigated acquisition scan (MUGA) scan or 2D-ECHO within normal limits for the institution
  • Have side effects (except alopecia) of prior treatment resolved to at least Grade 1 according to the National Cancer Institute - Common Terminology Criteria of Adverse Events (NCICTCAE) (Version 4.0)
  • Have a negative urine or serum pregnancy test at screening
  • Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

  • Diagnosis of ovarian carcinoma with mucinous histology
  • Had more than 2 prior lines of chemotherapy
  • Prior exposure to trabectedin or hypersensitivity to any of the excipients
  • Prior treatment with doxorubicin or other anthracycline at cumulative doses greater than 300 mg/m2 (calculated using doxorubicin equivalent doses: 1 mg doxorubicin = 1 mg Doxil/Caelyx = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)
  • Unwilling or unable to have a central venous catheter placed
  • Pregnant or breast-feeding
  • Less than 3 weeks from radiation therapy, experimental therapy, hormonal therapy, prior chemotherapy, or biological therapy
  • History of another neoplastic disease (except non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ adequately treated) unless in remission for 5 years
  • Known allergies, hypersensitivity, or intolerance to Doxil, dexamethasone, or their excipients
  • Known history of central nervous system metastasis
  • Known significant chronic liver disease, such as cirrhosis or active hepatitis (potential participants who test positive for hepatitis B surface antigen or hepatitis C antibodies are allowed provided they do not have active disease requiring antiviral therapy)
  • Had a myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
  • Has any of the following medical conditions: uncontrolled diabetes, psychiatric disorder (including dementia) that prevents compliance with protocol, uncontrolled seizures, newly diagnosed deep vein thrombosis, active systemic infection that is likely to interfere with study procedure or results
  • Has any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01846611

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Show 118 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
PharmaMar
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01846611     History of Changes
Other Study ID Numbers: CR100983, ET743OVC3006, 2012-004808-34
Study First Received: May 1, 2013
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration
Australia: National Health and Medical Research Council
New Zealand: Ministry of Health
China: Food and Drug Administration
Switzerland: Federal Office of Public Health
Israel: Israeli Health Ministry Pharmaceutical Administration
South Africa: Medicines Control Council
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Janssen Research & Development, LLC:
Ovarian neoplasms
Peritoneal neoplasms
Fallopian tube neoplasms
Advanced-relapsed epithelial ovarian cancer
Advanced-relapsed primary peritoneal cancer
Advanced-relapsed fallopian tube cancer
Trabectedin
Yondelis
Doxil
Caelyx
Platinum sensitive
Tthird-line
BRCA
Patient related outcome

Additional relevant MeSH terms:
Peritoneal Diseases
Neoplasms
Fallopian Tube Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Trabectedin
Doxorubicin
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014