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Paclitaxel/Carboplatin Combined With Intermittent Gefitinib in Patients With Untreated Advanced Non-small Cell Lung Cancer: A Phase Ⅱa Trial


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Paclitaxel/Carboplatin Combined With Intermittent Gefitinib in Patients With Untreated Advanced Non-small Cell Lung Cancer: A Phase Ⅱa Trial


OBJECTIVES:

Primary

- To determine the efficacy, in terms of overall response, and safety of paclitaxel and
carboplatin in combination with intermittent gefitinib in patients with advanced
nonsquamous non-small cell lung cancer.

Secondary

- Determine the disease-control rate in patients treated with this regimen.

- Determine the quality of life of patients treated with this regimen.

- Determine the progression-free and overall survival of patients treated with this
regimen.

OUTLINE: Patients receive paclitaxel IV on day 1, carboplatin IV on day 2, and oral
gefitinib once daily on days 8-17. Treatment repeats every 21 days for 4 courses in the
absence of disease progression or unacceptable toxicity. After completion of 4 courses,
patients with complete response or partial response may continue maintenance therapy
comprising oral gefitinib once daily in the absence of disease progression or unacceptable
toxicity.

Patients complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) at baseline,
during study treatment, and after completion of study treatment for quality-of-life study.

After completion of study treatment, patients are followed every 2 months for 2 years and
then every 4 months thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- No squamous cell carcinoma

- Untreated Stage IIIB or IV disease not suitable for surgery or radiotherapy OR
patients with postoperative recurrence who had never been treated by chemotherapy

- No history of smoking or light smoking (< 10 packs a year and smoking abatement ≥ 15
years)

- At least 1 measurable tumor mass (length > 1.5 cm and width > 1.0 cm)

- No symptomatic brain metastases

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Absolute neutrophil count ≥ 2 x 10^9/L

- Platelet count ≥ 100 x 10^9/L

- ALT and AST ≤ 1.5 times upper limit of normal (ULN)

- Total bilirubin ≤1.5 times ULN

- Serum creatinine normal

- Creatinine clearance ≥ 50 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignant tumors within the past year except for basal cell or squamous cell
carcinoma of the skin, or in situ malignant cancer that has been completely resected

- No history of allergic reaction to any component of the drugs in this study

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 1 month since prior investigational drugs or medical devices

- No prior chemotherapy or radiotherapy for this tumor

- No concurrent liposomal paclitaxel

- No other concurrent antitumor therapy (e.g., radiotherapy or surgical treatment)

- No other concurrent anticancer chemotherapy drugs or anticancer Chinese herbs

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall-response rate

Safety Issue:

No

Principal Investigator

Yuankai Shi, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute Hospital, Chinese Academy of Medical Sciences

Authority:

Unspecified

Study ID:

CDR0000643743

NCT ID:

NCT01024712

Start Date:

May 2009

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • bronchoalveolar cell lung cancer
  • large cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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