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Combination Chemotherapy With CS-1008 to Treat Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT00945191
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : February 5, 2013
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE July 22, 2009
First Posted Date  ICMJE July 24, 2009
Last Update Posted Date February 5, 2013
Study Start Date  ICMJE September 2009
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2009)
percentage of subjects with complete response after 6 cycles of treatment based on RECIST criteria [ Time Frame: 18 weeks = 6 cycles ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00945191 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2009)
  • objective response rate (all subjects) [ Time Frame: 18 weeks = 6 cycles ]
  • duration of complete response [ Time Frame: 18 weeks = 6 cycles ]
  • overall survival (subjects that achieve a complete response) [ Time Frame: 18 weeks = 6 cycles ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy With CS-1008 to Treat Ovarian Cancer
Official Title  ICMJE Phase 2 Study of CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer
Brief Summary This is a trial to see what effects a combination therapy with CS-1008 and Paclitaxel/Carboplatin will have on a patient's response in locally advanced or metastatic ovarian cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: CS-1008
    CS-1008 IV infusion up to 10 mg/kg once every 3 weeks (1 cycle) for 6 cycles
  • Drug: paclitaxel
    paclitaxel 175 mg/m2 IV infusion once every 3 weeks (1 cycle) for 6 cycles
    Other Name: Taxol
  • Drug: carboplatin
    carboplatin (target area under the concentration versus time curve of 6.0 using the Calvert Formula) IV infusion once every 3 weeks (1 cycle) for 6 cycles
Study Arms  ICMJE Experimental: CS-1008 with paclitaxel and carboplatin
CS-1008 will be administered with paclitaxel and carboplatin.
Interventions:
  • Drug: CS-1008
  • Drug: paclitaxel
  • Drug: carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2012)
24
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2009)
40
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed, epithelial carcinoma of the ovary or primary peritoneal carcinoma (FIGO Stage IIIC or IV). (Subjects with the following histologic epithelial cell types are eligible for the study: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified.)
  • Enrollment within 6 weeks after surgical resection (debulking).
  • Residual tumor masses > 1 cm and objectively measurable/evaluable disease as defined by RECIST criteria.
  • No prior therapy for ovarian cancer (ie, chemotherapy or radiotherapy [RT] to the abdomen or pelvis) other than surgical debulking of disease.
  • At least 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Adequate organ and bone marrow function as evidenced by:

    • Absolute neutrophil count ≥ 1,500/µL (equivalent to NCI CTCAE, Version 3.0 grade 1)
    • Platelet count ≥ 100,000/µL (CTCAE grade 0 to 1)
    • Hemoglobin ≥ 9 g/dL
    • Serum creatinine ≤ 1.5 x institutional ULN (CTCAE grade 1)
    • Bilirubin ≤ 1.5 x ULN (CTCAE grade 1)
    • AST and alkaline phosphatase ≤ 2.5 x ULN (CTCAE grade 1)
  • Adequate neurologic function (ie, sensory and motor neuropathy ≤ CTCAE grade 1).
  • Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for 3 months thereafter.
  • All subjects of childbearing potential must have a negative pregnancy test (serum or urine) result ≤ 72 hours before initiating study treatment.
  • Subjects must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an IRB-approved ICF before performance of any study-specific procedures or tests.

Exclusion Criteria:

  • Prior invasive malignant disease within 5 years except for squamous cell or basal cell carcinoma.
  • Current diagnosis of borderline epithelial ovarian tumor (formerly "tumors of low malignant potential") or recurrent ovarian epithelial cancer.
  • Positive human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg) because of the potential for additional toxicity from the treatment regimen.
  • Anticipation of need for a major surgical procedure or RT during the study.
  • History of any of the following conditions within 6 months before study enrollment: myocardial infarction; severe/unstable angina pectoris; coronary/peripheral artery bypass graft; New York Heart Association (NYHA) class III or IV congestive heart failure; cerebrovascular accident or transient ischemic attack, pulmonary embolism, or other clinically significant thromboembolic event; clinically significant pulmonary disease (eg, severe chronic obstructive pulmonary disease or asthma).
  • Clinically active brain metastasis (ie, untreated, still requiring therapy with steroids or RT, or with progression within 4 weeks after completion of RT); an uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis.
  • Pregnant or lactating.
  • Prior treatment with CS-1008, other agonistic DR5 antibodies, or TRAIL.
  • Known history of hypersensitivity reactions to any of the components of CS-1008, paclitaxel (or docetaxel), or carboplatin formulations.
  • Serious intercurrent medical or psychiatric illnesses or any other conditions that in the opinion of the Investigator would impair the ability to give informed consent or unacceptably reduce protocol compliance or safety of the study treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00945191
Other Study ID Numbers  ICMJE CS1008-A-U205
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daiichi Sankyo, Inc.
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daiichi Sankyo, Inc.
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP