Efficacy and safety of weekly nab-paclitaxel plus CBDCA in patients with CUP

JRCT ID: jRCTs051180084

Registered date:28/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: cancer of unknown primary
• Date of first enrollment: 17/11/2013
• Target sample size: 28
• Study type: Interventional
• Intervention(s): Nab-paclitaxel is administered as a 30-minute infusion at a dose of 100mg/m2 on days 1,8,and 15 followed by carboplatin at an AUC of 6 mg.min/ml(per Calvert formula) given on day1, every 21 days. Responding patients and patients with stable disease have a six-cycle maximum.

Outcome(s)

• Primary Outcome: response rate
• Secondary Outcome: progression free survival, overall survival, adverse event

Key inclusion & exclusion criteria

• Age minimum: 20 years old =<
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients with histologically comfirmed metastatic malignant lesion, with no identifiable primary site by physical examination, imaging, and laboratory examination.
2)No indication for radical operation and radiotherapy.
3)Measurable disease according to RECIST(version1.1).
4)No prior chemotherapy for CUP.
5)ECOG scale: 0-1
6)Patient with enough feasibility for planned chemotherapy(hematological, liver, renal, cardiopulmonary function).
7)peripheral neuropathy <= Grade1
8)Patients who are expected to survive for more than 3 months.
9)Written informed consent.

Exclude criteria

1)Pregnancy or breast feeding.
2)Patients unable to take nab-paclitaxel and CBDCA because of significant cardiovascular abnormalities, renal dysfunctions, hepatic insufficiency, uncontrolled diabetes, uncontrolled hypertension, bleeding tendency, active interstitial pneumonia,etc.
3)Known HIV active hepatitis B, active hepatitis C, and/or other known severe infections, including but not limited tuberculosis.
4)Ascites, pleural effusion, pericardial effusion, which require regular drainage.
5)Any other active malignancy unless free of disease for at least five years.
6)Known active brain metastasis.
7)Known hypersensitivity to any of platinum drugs, paclitaxel, and albumin containing drugs.
8)Known hypoadrealism which requires treatment
9)Specific clinicopathologic subgroups which have effective management.
a)Woman with isolated axillary lymph node metastasis.
b)Patients with CUP presenting as metastatic cervical or isolated inguinal lymphadenopathy(squamous cell carcinoma).
c)Men with features of the extra gonadal germ cell cancer syndrome.
d)Men with features of prostate cancer(adenocarcinoma, elevated level of PSA, and osteoblastic bone metastasis).
e)Neuroendcrine tumors.

Related Information

• Primary Sponsor: Yagi Toshinari
• Secondary ID(s): UMIN000012204