Combination Chemotherapy With CS-1008 to Treat Ovarian Cancer

NCT ID: NCT00945191

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-06
• Study Completion Date: 2011-08-23

Brief Summary

This trial assessed the effect of treatment with CS-1008 in combination with paclitaxel/carboplatin on response in patients with locally advanced or metastatic ovarian cancer.

Detailed Description

This trial assessed CS-1008 administered in combination with paclitaxel/carboplatin to patients with Stage IIIC or IV ovarian cancer who had suboptimal debulking surgery with residual measurable/evaluable disease and who had not received prior therapy for their disease. The effect of this first-line treatment in patients was assessed by complete response rate.

Conditions

Ovarian Cancer Stage IIIC; Ovarian Cancer Stage IV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CS-1008 with paclitaxel and carboplatin

CS-1008 will be administered with paclitaxel and carboplatin.

Group Type: EXPERIMENTAL

CS-1008

Intervention Type: DRUG

CS-1008 intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6

Paclitaxel

Intervention Type: DRUG

Paclitaxel 175 mg/m\^2 IV infusion once every 3 weeks (1 cycle) for 6 cycles

Carboplatin

Intervention Type: DRUG

Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) IV infusion once every 3 weeks (1 cycle) for 6 cycles

Interventions

CS-1008

CS-1008 intravenous (IV) infusion 10 mg/kg on Day 1 of Cycle 1 and 8 mg/kg once every 3 weeks (1 cycle) for Cycle 2-6

Intervention Type: DRUG

Paclitaxel

Paclitaxel 175 mg/m\^2 IV infusion once every 3 weeks (1 cycle) for 6 cycles

Intervention Type: DRUG

Carboplatin

Carboplatin (target area under the concentration versus time curve of 6.0 mg/mL/min using the Calvert Formula) IV infusion once every 3 weeks (1 cycle) for 6 cycles

Intervention Type: DRUG

Other Intervention Names

Taxol

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed, epithelial carcinoma of the ovary or primary peritoneal carcinoma (International Federation of Gynecology and Obstetrics [FIGO] Stage IIIC or IV).

(Participants 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 Response Evaluation Criteria in Solid Tumors (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 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (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 upper limit of normal (ULN) (CTCAE grade 1)
• Bilirubin ≤ 1.5 x ULN (CTCAE grade 1)
• Aspartate aminotransferase (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.
• Participants 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 institutional review board-approved informed consent form (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 radiotherapy (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 tumor necrosis factor-related apoptosis inducing ligand (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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

Univ. Alabama

Birmingham, Alabama, United States

Barnes Jewish Hospital

St Louis, Missouri, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

CS1008-A-U205

Identifier Type: -

Identifier Source: org_study_id