Combination Chemotherapy With CS-1008 to Treat Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00945191
First received: July 22, 2009
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Ovarian Cancer
Drug: CS-1008
Drug: paclitaxel
Drug: carboplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • percentage of subjects with complete response after 6 cycles of treatment based on RECIST criteria [ Time Frame: 18 weeks = 6 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • objective response rate (all subjects) [ Time Frame: 18 weeks = 6 cycles ] [ Designated as safety issue: No ]
  • duration of complete response [ Time Frame: 18 weeks = 6 cycles ] [ Designated as safety issue: No ]
  • overall survival (subjects that achieve a complete response) [ Time Frame: 18 weeks = 6 cycles ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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.
  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: NCT00945191

Locations
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.
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00945191     History of Changes
Other Study ID Numbers: CS1008-A-U205
Study First Received: July 22, 2009
Last Updated: February 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
ovarian
cancer
metastatic
locally
advanced
chemotherapy
neoplasm

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014