CS-1008 With Carboplatin/Paclitaxel in Chemotherapy naïve Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00991796
First received: October 7, 2009
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to determine the effect on toxicity of the addition of CS 1008 to a platinum based chemotherapy regimen on the progression-free survival (PFS) in subjects with stage IIIB wet or stage IV NSCLC.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: CS-1008
Drug: Placebo
Drug: Paclitaxel
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomised, Double-Blinded, Placebo Controlled, Phase 2 Study of CS-1008 in Combination With Carboplatin/Paclitaxel in Chemotherapy naïve Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Difference in progression-free survival (PFS) of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in overall survival of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Difference in objective response rate (ORR) of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Difference in duration of response of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 109
Study Start Date: June 2009
Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CS-1008
CS-1008 with carboplatin and paclitaxel
Drug: CS-1008
CS-1008 powder for concentrate for solution for infusion. six cycles of combination therapy with 3 weeks equal to one cycle. 10 mg/kg
Drug: Paclitaxel
Paclitaxel concentrate for solution for infusion. once every 3 weeks for a maximum of 6 cycles. 175 mg/m2
Other Name: Taxol
Drug: Carboplatin
Carboplatin concentrate for solution for infusion. once every 3 weeks for a maximum of 6 cycles. 6 mg/m2
Other Name: Paraplatin
Placebo Comparator: Placebo
Placebo with carboplatin and paclitaxel
Drug: Placebo
Placebo
Drug: Paclitaxel
Paclitaxel concentrate for solution for infusion. once every 3 weeks for a maximum of 6 cycles. 175 mg/m2
Other Name: Taxol
Drug: Carboplatin
Carboplatin concentrate for solution for infusion. once every 3 weeks for a maximum of 6 cycles. 6 mg/m2
Other Name: Paraplatin

  Eligibility

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

Inclusion Criteria:

  • At least 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Measurable disease as defined by RECIST criteria
  • Adequate organ and bone marrow function as evidenced by:

    • Hemoglobin >= 9 g/dL;
    • ANC >= 1.5 x 109/L;
    • Platelet count >= 100 x 109/L;
    • Serum creatinine < 1.5 mg/dL or creatinine clearance > 60 mL/min;
    • AST, ALT, and alkaline phosphatase <= 2.5 x upper limit of normal (ULN) if without liver metastasis and <= 5.0 x ULN if liver metastasis;
    • Total bilirubin <= 2.0 x ULN.
  • Men and women of childbearing potential must be willing to consent to using effective double barrier contraception (eg, hormonal contraceptives, bilateral tubal ligation, barrier with spermicidal, intrauterine device) while on treatment and for 3 months thereafter.
  • All female 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 IEC approved ICF before performance of any study specific procedures or tests.

Exclusion Criteria:

  • Anticipation of need for a major surgical procedure or radiotherapy (RT) during the study.
  • Prior treatment with chemotherapy for their disease.
  • History of any of the following conditions within 6 months before study enrolment: myocardial infarction; New York Heart Association (NYHA) class II or higher severe/unstable angina pectoris; coronary/peripheral artery bypass graft; 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 significant pulmonary edema or anasarca.. See Section 17.2 for NYHA Classification.
  • Clinically significant pleural or pericardial effusions.
  • Grade 2 or higher current peripheral neuropathy (See Section 17.3; NCI CTCAE, Version 3.0).
  • 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.
  • History of malignancy other than NSCLC, unless there is the expectation that the malignancy has been cured, and tumor specific treatment for the malignancy has not been administered within the previous 5 years.
  • Clinically significant active infection that requires antibiotic therapy or Human Immunodeficiency Virus (HIV) positive subjects receiving antiretroviral therapy.
  • Previous treatment with chemotherapy, CS 1008, other agonistic DR 5 or DR 4 antibodies, or with TRAIL.
  • Pregnant or breast feeding.
  • Known history of hypersensitivity reactions to any of the components of CS 1008, carboplatin, or paclitaxel 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: NCT00991796

Locations
Germany
Asklepios Fachkliniken Munchen Gauting
Gauting, Germany
Zentrum fur Pneumologie und Thoraxchirurgie
Grobhansdorf, Germany
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided by Daiichi Sankyo Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00991796     History of Changes
Other Study ID Numbers: CS1008-A-E202
Study First Received: October 7, 2009
Last Updated: September 7, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
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 September 15, 2014