Overview

Combination Chemotherapy With CS-1008 to Treat Ovarian Cancer

Status:
Completed
Trial end date:
2011-08-23
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Daiichi Sankyo Inc.
Daiichi Sankyo, Inc.
Treatments:
Albumin-Bound Paclitaxel
Carboplatin
Paclitaxel
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.