Know Cancer

or
forgot password

A Randomized Phase II Clinical Trial of Nab-Paclitaxel and Carboplatin Compared With Gemcitabine and Carboplatin as First-line Therapy in Advanced Squamous Cell Carcinoma of Lung


Phase 2
18 Years
85 Years
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

A Randomized Phase II Clinical Trial of Nab-Paclitaxel and Carboplatin Compared With Gemcitabine and Carboplatin as First-line Therapy in Advanced Squamous Cell Carcinoma of Lung


Albumin-bound paclitaxel(nab-P) utilizes the albumin binding proteins,such as
(gp60)/caveolin-1 (CAV1) and SPARC(secreted protein acidic and rich in cysteine), achieving
high intratumoral paclitaxel accumulation. It is reported that CAV1 is overexpressed in
squamous cell cancer(SQC), so it is possible that nab-PC is more highly active than GC in
SQC of lung.


Inclusion Criteria:



- Previously untreated, histological documented stage IIIB (not amenable for radical
regional therapy) or stage IV squamous cell carcinoma of lung. At least one
measurable lesion as defined by RECIST criteria.

- At least 18 years of age.

- ECOG PS 0~1

- Patients have no previously malignant tumor history except cured cervical carcinoma
in situ, basal cell carcinoma or superficial bladder cancer. Patients are also
eligible if they have received a chemotherapy regimen as neoadjuvant or adjuvant
chemotherapy and the disease recurred over 12 months since the finishing of
neoadjuvant or adjuvant chemotherapy.

- neutrophil ≥ 1.5 x 109 /L, Hemoglobin > 90 g/L, Platelet count > 100x109/L.

- Total bilirubin ≤ 1.5 x upper limit of normal. ALT and AST < 2.5 x upper limit of
normal without liver metastasis, ALT and AST < 5 x upper limit of normal with liver
metastasis. Serum creatinine < 1.5 x upper limit of normal.

- Urine pregnancy test is negative for woman.

- Estimated life expectancy is at least 3 months.

- Patient comply with the clinical trial protocal.

- Informed consent must be signed.

Exclusion Criteria:

- Patients who are currently undergoing other anti-tumor therapy.

- Patients who was enrolled in any other clinical trial within 4 weeks of study entry.

- Any physical examination finding, or clinical laboratory finding giving reasonable
suspicion of a disease or condition that contraindicates the use of any study
medication or render the subject at high risk from treatment.

- Central nervous system (CNS) tumor or metastatic tumor.

- Serious mental disorder.

- Serious dysgnosia.

- Other serious comorbidity.

- Alcohol or drug dependence.

- Previously allergic to drugs used in the study.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate(ORR)

Outcome Description:

ORR is evaluated after at most 6 cycles of chemotherapy, which may cost 18 weeks.

Outcome Time Frame:

18weeks

Safety Issue:

No

Principal Investigator

Wu Yilong, professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Guangdong General Hospital

Authority:

China: Food and Drug Administration

Study ID:

C-TONG1002

NCT ID:

NCT01236716

Start Date:

November 2010

Completion Date:

June 2014

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • squamous cell carcinoma of lung
  • Albumin bound paclitaxel
  • chemotherapy
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Lung Neoplasms

Name

Location