Carcinoma, Non-Small-Cell LungPhase 1NCT00497250
Phase I Study of Iressa and CRT/IMRT in Chinese Patients With IIIB/IV NSCLC After Failure of Platinum-Based Chemotherapy
A Phase 1 study testing Gefitinib and Radiation Therapy in people with Carcinoma, Non-Small-Cell Lung, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Gefitinib and Radiation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- Jul 2007to Oct 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 1 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
- Platelets ≥100,000/µL
- Total bilirubin<1.5 X upper limit of normal
- AST (SGOT)/ALT (SGPT) ≤2.5 X institutional upper limit of normal
- Creatinine ≤ 2.5 mg/dl.
- Recovery from any acute toxicity related to prior therapy(CTC<2)
Who cannot join
- 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
Show all 23Show fewer
- <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)
- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St.John's Wort
- Other uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements
- Surgical incision from major surgery not healed
- Bleeding after biopsy(except small biopsy)
- Use a non-approved or investigational drug within 30 days before Day 1 of the trial treatment
- No measurable disease
- Pregnancy or lactating
- Receiving other investigational agents or devices
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University, Cancer Hospital, Department of Radiation Oncology
Shanghai, 200031
Lin Ding, RS, 862164175590 ext. 1407
About this study
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.
Read the detailed description
Laboratory research has suggested that targeting specific signalling proteins would be well suited for selectively enhancing the tumor radiosensitivity. In human xenograft models (non-small cell lung cancer and breast cancer) treated with gefitinib and irradiation, combined therapy has shown a significant increase in tumor growth delay as compared with monotherapy of irradiation or gefitinib. The epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 selectively potentiates radiation response of human tumors in nude mice, with a marked improvement in therapeutic index. The authors concluded that gefitinib profoundly enhanced the antitumor action of RT against the tested tumors without significant adverse effects, increasing the therapeutic selectively of ionizing radiation in certain model systems. Substantial benefits for this multimodality therapy in patients could be expected.
While there are no published data on the feasibility and efficacy of combined gefitinib and radiation therapy in Chinese population who might be susceptible to gefitinib monotherapy, clinical studies have demonstrated that combining gefitinib with external beam radiation to 66-74Gy and concurrent weekly chemotherapy after induction chemotherapy were tolerated without excessive toxicity. In the present trail, we hope to build on our own experience of using combined gefitinib and thoracic radiation with 3D-CRT or intensity-modulated radiotherapy (IMRT) technique in a phase I setting for stage IIIb and selected stage IV NSCLC. We will follow this treatment (RT and gefitinib) with 60 days gefitinib at standard systemic doses.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Gefitinib, Radiation Therapy
- Keywords
- Phase 1 Clinical Trials, Iressa, radiation therapy, Chinese, NSCLC, chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
Also called Iressa@
gefitinib 250 mg/day,PO concurrent with RT and 250 mg/day,PO for 60 days after the completion of RT.
Radiation TherapyDevice
Also called 3-D CRT and IMRT
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Gefitinib; Device: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities per protocol
Measured: 3, 6 and 12 months
Secondary outcomes (2)
Response rate, mortality
Measured: 3, 6 and 12 months
Pattern of failure(e.g., local, regional, or distant metastasis)
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2009 (estimated)
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- Guoliang Jiang, MD, Principal investigator, Fudan University Cancer Hospital, Department of Radiation OncologyMin Fan, M.D., Principal investigator, Fudan University Cancer Hospital, Department of Radiation OncologyXiaolong Fu, M.D, Principal investigator, Fudan University Cancer Hospital, Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497250
- Sponsor's protocol ID
- FDCA001
- Status last verified
- Oct 2008
- First submitted
- 5 Jul 2007
- Last updated
- 21 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Iressa and CRT/IMRT in Chinese Patients With IIIB/IV NSCLC After Failure of Platinum-Based Chemotherapy
- ClinicalTrials.gov ID
- NCT00497250
- Acronym / sponsor ID
- FDCA001
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Phase 1 Clinical Trials, Iressa, radiation therapy, Chinese, NSCLC, chemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 6 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Laboratory research has suggested that targeting specific signalling proteins would be well suited for selectively enhancing the tumor radiosensitivity. In human xenograft models (non-small cell lung cancer and breast cancer) treated with gefitinib and irradiation, combined therapy has shown a significant increase in tumor growth delay as compared with monotherapy of irradiation or gefitinib. The epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 selectively potentiates radiation response of human tumors in nude mice, with a marked improvement in therapeutic index. The authors concluded that gefitinib profoundly enhanced the antitumor action of RT against the tested tumors without significant adverse effects, increasing the therapeutic selectively of ionizing radiation in certain model systems. Substantial benefits for this multimodality therapy in patients could be expected.
While there are no published data on the feasibility and efficacy of combined gefitinib and radiation therapy in Chinese population who might be susceptible to gefitinib monotherapy, clinical studies have demonstrated that combining gefitinib with external beam radiation to 66-74Gy and concurrent weekly chemotherapy after induction chemotherapy were tolerated without excessive toxicity. In the present trail, we hope to build on our own experience of using combined gefitinib and thoracic radiation with 3D-CRT or intensity-modulated radiotherapy (IMRT) technique in a phase I setting for stage IIIb and selected stage IV NSCLC. We will follow this treatment (RT and gefitinib) with 60 days gefitinib at standard systemic doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Gefitinib, Device: Radiation TherapyThoracic 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GefitinibAlso: Iressa@gefitinib 250 mg/day,PO concurrent with RT and 250 mg/day,PO for 60 days after the completion of RT. | Drug | 1 |
| Radiation TherapyAlso: 3-D CRT and IMRTgroup 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 | Device | 1 |
Primary outcome
Dose-limiting toxicities per protocol
Time frame: 3, 6 and 12 months
2 secondary outcomes
Response rate, mortality
Time frame: 3, 6 and 12 months
Pattern of failure(e.g., local, regional, or distant metastasis)
Time frame: 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoliang Jiang, MD principal investigator
Fudan University Cancer Hospital, Department of Radiation Oncology
Min Fan, M.D. principal investigator
Fudan University Cancer Hospital, Department of Radiation Oncology
Xiaolong Fu, M.D principal investigator
Fudan University Cancer Hospital, Department of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gefitinib and Radiation Therapy in people with Carcinoma, Non-Small-Cell Lung, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Fan, MD (8621-64175590 ext. 1406, fanming1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities per protocol (time frame: 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2008.