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Combination Chemotherapy With CS-1008 to Treat Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00945191
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : February 5, 2013
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: CS-1008 Drug: paclitaxel Drug: carboplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer
Study Start Date : September 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: CS-1008 with paclitaxel and carboplatin
CS-1008 will be administered with paclitaxel and carboplatin.
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

Primary Outcome Measures :
  1. percentage of subjects with complete response after 6 cycles of treatment based on RECIST criteria [ Time Frame: 18 weeks = 6 cycles ]

Secondary Outcome Measures :
  1. objective response rate (all subjects) [ Time Frame: 18 weeks = 6 cycles ]
  2. duration of complete response [ Time Frame: 18 weeks = 6 cycles ]
  3. overall survival (subjects that achieve a complete response) [ Time Frame: 18 weeks = 6 cycles ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00945191

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United States, Alabama
Univ. Alabama
Birmingham, Alabama, United States, 35233
United States, Missouri
Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Daiichi Sankyo, Inc.

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Responsible Party: Daiichi Sankyo, Inc. Identifier: NCT00945191     History of Changes
Other Study ID Numbers: CS1008-A-U205
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013
Keywords provided by Daiichi Sankyo, Inc.:
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action