A randomised phase II study evaluating two schedules of the 21-day regimen of Gemcitabine and Carboplatin in advanced NSCLC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000744-17-BE

Enrollment

Registered

2006-03-01

Start date

2006-03-22

Completion date

Unknown

Last updated

2014-10-27

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

Trade Name: Gemzar 200 Product Name: Gemzar Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Gemcitabine hydrochloride CAS Number: 122111-03-9 Concentration unit: mg milligr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with histologically or cytological proven NSCLC, stage IIIB with malignant pleural fluid and/or involved supraclavicular lymph nodes or stage IV. All tumour extensions will be classified according to TNM atlas. - At least 1 one-dimensional measurable lesion. - Chemotherapy-naive patients. - WHO 0-1 - Physically and mentally fit enough to receive Carboplatin Gemcitabine chemotherapy. - At the start of treatment: Hb > or = 6.0 mmol/l (9.66 g/dl) WBC > or = 3.0 x 109/l ANC > or = 1.5 x 109/l Platelets > or = 100 x 109/l Creatinine or = 50 ml/min calculated according to Cockroft-Gault’s formula: (weight (kg) x (140-age)/k x creat (mmol/l where k=0.96 for female and k = 0.814 for male. - Age =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with one or several of the following criteria are not eligible: - Weight loss of > 10 % body weight in the month prior to registration. - Other malignancies (previous or current), except adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, or if previous malignancy was more than 5 years prior and there are no signs of recurrence. - Pregnancy and/or breast feeding - Use of any investigational agent in the month before enrolment into the study. - Uncontrolled infections - Usage of haematological growth factors

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the haematological toxicity of the combination of Gemcitabine 1250 mg/m² d1, 8 and Carboplatin AUC 5 on d8 every 3 weeks and to compare this with Gemcitabine 1250 mg/m² on d1, 8 and Carboplatin AUC 5 on d1 every 3 weeks in patients with advanced non-small cell lung cancer. ;Secondary Objective: To compare response rate, non-hematologic toxicity and dose intensity profile of the two Gemcitabine-Carboplatin combinations in patients with advanced NSCLC. Side effects will be graded according to the “Common Toxicity Criteria” defined by the NCI (US) and extended by the NCIC (Canada);Primary end point(s): The primary end-points of this phase II trial are: 1. Haematological toxicity 2. Response rates	—

Measure

Time frame

Main Objective: To assess the haematological toxicity of the combination of Gemcitabine 1250 mg/m² d1, 8 and Carboplatin AUC 5 on d8 every 3 weeks and to compare this with Gemcitabine 1250 mg/m² on d1, 8 and Carboplatin AUC 5 on d1 every 3 weeks in patients with advanced non-small cell lung cancer. ;Secondary Objective: To compare response rate, non-hematologic toxicity and dose intensity profile of the two Gemcitabine-Carboplatin combinations in patients with advanced NSCLC. Side effects will be graded according to the “Common Toxicity Criteria” defined by the NCI (US) and extended by the NCIC (Canada);Primary end point(s): The primary end-points of this phase II trial are: 1. Haematological toxicity 2. Response rates

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026