Determination of the toxicity of standard dose cetuximab together with concurrent individualised, isotoxic accelerated radiotherapy and cisplatin - vinorelbine for patients with stage III non-small cell lung cancer (NSCLC): a phase I study.

Determination of the toxicity of standard dose cetuximab together with concurrent individualised, isotoxic accelerated radiotherapy and cisplatin - vinorelbine for patients with stage III non-small cell lung cancer (NSCLC): a phase I study. - Phase I cetuximab and concurrent radio-chemotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35459

Enrollment

Registered

2007-05-02

Start date

2007-09-17

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

40 mg/m2 day 43. Vinorelbine will be escalated in three steps: Step 1: 10 mg/ m2 days 22, 29

8 mg/m2 days 43 and 50. Step 2: 20 mg/ m2 days 22, 29

8 mg/m2 days 43 and 50. Step 3: 20 mg/ m2 days 22, 29

15 mg/m2 days 43 and 50.

Eligible patients receive 1 cycle of carboplatin (AUC 5) day 1 and gemcitabine (1250 mg/m2) days 1,8. One cycle duration is 21 days. Patients without progressive disease (PD) according to the RECIST

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Histologically confirmed non-small cell lung cancer - Inoperable stage III (UICC 2002; sixth edition) (no pleural effusion) - WHO performance status 0 or 1 - Less than 10% weight loss in the last 6 months - Lung function: FEV1 at least 50% and DLCO at least 50% of the predicted value - No recent severe cardiac disease - Adequate bone marrow function - Adequate renal function - Adequate hepatic function - Life expectancy more than 6 months - Measurable cancer - Willing and able to comply with study prescriptions - 18 years or older - Not pregant or breast feeding - Written informed consent - No previous raditherapy to the chest

Exclusion criteria

Exclusion criteria: - Not non-small cell lung cancer histology - Mixed pathology - History of prior chest radiotherapy - Recent (

Design outcomes

Primary

Measure	Time frame
The MTD will be reached when in a certain step 2/6 or more patients develop grade 3 or more pneumonitis and / or when 3/6 or more patients develop grade 3 or more acute esophagitis and /or when 2/6 patients develop grade 3 or more diarrhea, renal or liver toxicity. In case that 1/6 patients develops G4 skin toxicity and / or G4 neuropathy and / or G5 hematological toxicity, another 6 patients will be enrolled at that dose level. If again 1/6 patients develops the latter toxicity, DLT will be reached. Furthermore, the MTD will be reached when at maximum one patient may have an at 3 months post-treatment persistent G3 or more other toxicity. The decision to move to another dose-level of vinorelbine will be taken when the minimum follow-up of each patient in a particular dose-level will be 3 months post-radiation.	—

Measure

Time frame

The MTD will be reached when in a certain step 2/6 or more patients develop grade 3 or more pneumonitis and / or when 3/6 or more patients develop grade 3 or more acute esophagitis and /or when 2/6 patients develop grade 3 or more diarrhea, renal or liver toxicity. In case that 1/6 patients develops G4 skin toxicity and / or G4 neuropathy and / or G5 hematological toxicity, another 6 patients will be enrolled at that dose level. If again 1/6 patients develops the latter toxicity, DLT will be reached. Furthermore, the MTD will be reached when at maximum one patient may have an at 3 months post-treatment persistent G3 or more other toxicity. The decision to move to another dose-level of vinorelbine will be taken when the minimum follow-up of each patient in a particular dose-level will be 3 months post-radiation.

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Secondary

Measure	Time frame
. Dysphagia (CTC 3.0) during and after chemo-radiation . Cough (CTC 3.0) during and after chemo-radiation . Dyspnoa (CTC 3.0) during and after chemo-radiation . Skin rash associated with chemo-radiation (CTC 3.0) during and after chemo-radiation . Myelitis (CTC 3.0) after chemo-radiation . Neuropathy (CTC 3.0) during and after chemo-radiation . Neutrophiles (CTC 3.0) during and after chemo-radiation . Platelets (CTC 3.0) during and after chemo-radiation . Hemoglobine (CTC 3.0) during and after chemo-radiation . Diarree (CTC 3.0) tijdens en na chemo-radiation . Renal failure (CTC 3.0) during and after chemo-radiation . Lever dysfunctie (CTC 3.0) tijdens en na chemo-radiation . Tumour response 3 months after end chemo-radiation (FDG-PET-CT scan) . Survival	—

Measure

Time frame

. Dysphagia (CTC 3.0) during and after chemo-radiation . Cough (CTC 3.0) during and after chemo-radiation . Dyspnoa (CTC 3.0) during and after chemo-radiation . Skin rash associated with chemo-radiation (CTC 3.0) during and after chemo-radiation . Myelitis (CTC 3.0) after chemo-radiation . Neuropathy (CTC 3.0) during and after chemo-radiation . Neutrophiles (CTC 3.0) during and after chemo-radiation . Platelets (CTC 3.0) during and after chemo-radiation . Hemoglobine (CTC 3.0) during and after chemo-radiation . Diarree (CTC 3.0) tijdens en na chemo-radiation . Renal failure (CTC 3.0) during and after chemo-radiation . Lever dysfunctie (CTC 3.0) tijdens en na chemo-radiation . Tumour response 3 months after end chemo-radiation (FDG-PET-CT scan) . Survival

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)