Phase I Study of Iressa and CRT/IMRT in Chinese Patients With IIIB/IV NSCLC After Failure of Platinum-Based Chemotherapy

NCT00497250 | Unknown Phase 1 DMC

• 1 other identifier: FDCA001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the tolerability and the maximum tolerated dose of Conformal or Intensity-Modulated Radiotherapy when given in combination with gefitinib 250mg in Chinese patients with IIIB or IV NSCLC after failure of platinum-based chemotherapy. Secondary objectives of the study are to obtain the preliminary information on efficacy after concomitant treatment of gefitinib 250mg and radiotherapy in Chinese patients with IIIB or IV NSCLC after failure of platinum-based chemotherapy, as measured by RECIST criteria. To determine the pattern of failure (e.g., local, regional, or distant metastasis) in patients treated with this regimen.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Phase 1 Clinical Trials; Iressa; radiation therapy; Chinese; NSCLC; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicities per protocol

  3, 6 and 12 months

Secondary Outcomes (2)

• Response rate, mortality

  3, 6 and 12 months

• Pattern of failure(e.g., local, regional, or distant metastasis)

  3, 6 and 12 months

Study Arms (1)

1

OTHER

Thoracic RT for patients will start from 54Gy, and then escalate dose at 2Gy increment to 60Gy. At each dose level, 8 patients are required to complete RT without dose limiting toxicity(DLT). Evaluation will be done after 8 patients have completed the treatment.If there are \>=2 DLT in the first 8 patients, the maximum tolerated dose (MTD) is achieved. If there is a single DLT revealed, an additional 8 patients will be recruited to that dose level. Should there be severe complication occurred again be at least 1 more DLT, then MTD is thought to be achieved.Hence,MTD will be achieved if at least 2 out of the first 8 patients have a DLT,or if a further 8 patents are recruited, \>=2 out of 16 patients have a DLT. Concurrent with RT, patients will be given gefitinib 250 mg/day PO as well as same dose PO for 60 days after the completion of RT.

Drug: Gefitinib; Device: Radiation Therapy

Interventions

Gefitinib DRUG

gefitinib 250 mg/day,PO concurrent with RT and 250 mg/day,PO for 60 days after the completion of RT.

Also known as: Iressa@

1

Radiation Therapy DEVICE

group 1.54Gy/27Fx concurrent with gefitinib group 2.56Gy/28Fx concurrent with gefitinib group 3.58Gy/29Fx concurrent with gefitinib group 4.60Gy/30Fx concurrent with gefitinib

Also known as: 3-D CRT and IMRT

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and willing to sign the consent
• Provision of study-specific written informed consent
• Chinese ethnicity
• Histological or cytological conformation of NSCLC(maybe from initial diagnosis of NSCLC or subsequent biopsy). Of note,sputum cytology alone is not acceptable. Cytological specimens obtained by brushing, washing and needle aspiration of a defined lesion are acceptable
• Stage IIIB or stage IV,excluding those with pericardial or uncontrolled (not stable in past 60 days) pleural effusion. Stage IV patients must either be symptomatic due to pulmonary malignancies or only have CNS or bone metastases if there is clinical evidence of stable disease (no steroid therapy or steroid dose being tapered) for ≥28 days.
• ≥ 1 prior chemotherapy regimen (at least one platinum-based) for treatment of their disease and will have been progressed or intolerant to their most recent prior chemotherapy
• FEV1≥ 1000cc (without bronchodilator)
• FEV1/FVC \>0.7 (with or without bronchodilator) or post-bronchodilator FEV1/FVC ≤0.7 but FEV1≥ 50% of predicted value
• measurable lesion according to RECIST criteria
• Life expectancy of ≥24 weeks
• Zubord-ECOG criteria performance status0-2(Karnofsky\>60%)
• Normal organ and marrow function as defined below:
• Leukocytes≥3,000/µL
• Haemoglobin≥9g/dL (prior to transfusions)
• Absolute neutrophil count ≥1,500/µL

You may not qualify if:

• Prior iressa therapy or prior therapy with an experimental agent whose primary mechanism of action is inhibition of EGFR or Pan-HER family receptors or its associated tyrosine kinase
• Prior thoracic radiotherapy
• Prior palliative RT whose port involved the lung or mediastinum region
• Newly diagnosed CNS metastases that have not been treated with surgery and/or radiation
• Newly diagnosed painful bony metastases w/o cord compression yet not treated with surgery and/or radiation
• Evidence of visceral metastases
• \<21 days since prior chemotherapy, immunotherapy, or biological systemic anticancer therapy
• \<28 days since prior cranial and/or bone irradiation
• Unresolved chronic or late toxicity from previous anticancer therapy inappropriate for this study according to the investigator
• Allergic reactions attributed to compounds of similar chemical or biologic composition to iressa
• Other co-existing malignancies or malignancies diagnosed within the last 5 years except basal cell carcinoma or cervical cancer in situ
• Unable to ingest oral medications
• Any co-morbid pulmonary disease that may put the patient at risk of severe toxicities. Specially,
• Clinically active interstitial lung disease unless due to uncomplicated progressive lymphangitic carcinomatosis (except chronic stable radiographic changes who are asymptomatic)
• Severe chronic obstructive pulmonary disease (COPD) defined as post-bronchodilator FEV1/FVC ≤0.7 and FEV1 ≤ 50% of predicted value (American Thoracic Society (ATS) classification)

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University, Cancer Hospital, Department of Radiation Oncology

Shanghai, 200031, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib; Radiotherapy; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted

Study Officials

• Guoliang Jiang, MD

  Fudan University Cancer Hospital, Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

• Min Fan, M.D.

  Fudan University Cancer Hospital, Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

• Xiaolong Fu, M.D

  Fudan University Cancer Hospital, Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Fan, MD

CONTACT

8621-64175590; fanming1@yahoo.com

Xuwei Cai, MD

CONTACT

8621-64175590; birdhome2000@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2007
• First Posted: July 6, 2007
• Study Start: July 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 21, 2008

Record last verified: 2008-10

Locations

CN (1)