Combination Chemotherapy With CS-1008 to Treat Ovarian Cancer

NCT00945191 | Completed Phase 2 Results

• 1 other identifier: CS1008-A-U205
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

Ovarian Cancer Stage IIIC; Ovarian Cancer Stage IV

Keywords

Ovarian Cancer Stage IIIC; Ovarian Cancer Stage IV; CS-1008; Paclitaxel; Carboplatin

Outcome Measures

Primary Outcomes (1)

• Best Overall Response and Objective Response Rate Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer

  The best overall response is the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], unconfirmed CR, unconfirmed PR, stable disease \[SD\], and progressive disease \[PD\]) among all overall responses recorded from the start of treatment until the participant withdraws from the study. If there is no tumor assessment after the first dose of study drug, the best overall response is classified as Inevaluable. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD defined as at least a 20% increase in the sum of diameters of target lesions. Objective response rate was defined as confirmed CR and confirmed PR.

  Baseline up to first documented objective response, disease progression, or study withdrawal, up to 1 year 10 months

Secondary Outcomes (2)

• Change From Baseline in the Sum of Longest Diameters of Target Lesions Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer

  Baseline to Cycle 3, Week 3 Day 1; Cycle 6, Week 3 Day 1 (each cycle 21 days) up to end of study, approximately 1 year 10 months postdose

• Participants With Treatment-Emergent Adverse Events Grade 3 or Higher by System Organ Class and Preferred Term Following Treatment With CS-1008 in Combination With Chemotherapy (Paclitaxel/Carboplatin) in Locally Advanced or Metastatic Ovarian Cancer

  Baseline up to 30 days after last dose, up to 1 year 10 months postdose

Study Arms (1)

CS-1008 with paclitaxel and carboplatin

EXPERIMENTAL

CS-1008 will be administered with paclitaxel and carboplatin.

Drug: CS-1008; Drug: Paclitaxel; Drug: Carboplatin

Interventions

CS-1008 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

CS-1008 with paclitaxel and carboplatin

Paclitaxel DRUG

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

Also known as: Taxol

CS-1008 with paclitaxel and carboplatin

Carboplatin 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

CS-1008 with paclitaxel and carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (3)

Univ. Alabama

Birmingham, Alabama, 35233, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

tigatuzumab; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Contact of Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

908-992-6400

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 24, 2009
• Study Start: October 6, 2009
• Primary Completion: August 23, 2011
• Study Completion: August 23, 2011
• Last Updated: April 8, 2021
• Results First Posted: November 18, 2020

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)