Phase 1 study of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with limited-disease small cell lung cancer (LD-SCLC).

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR937
• Date of registration: 20/03/2007
• Primary sponsor: Erasmus Medical Center - Daniel den Hoed Kliniek, afdeling Interne Oncologie
• Public title: Phase 1 study of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with limited-disease small cell lung cancer (LD-SCLC).
• Scientific title: Phase 1 study of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with limited-disease small cell lung cancer (LD-SCLC). - N/A
• Date of first enrolment: 6/1/2003
• Target sample size: 9
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=937
• Study type: intervention
• Study design: Randomised: No; Masking: None; Control: Not applicable; Group: Parallel; Type: [default]

Countries of recruitment

The Netherlands

Contacts

• Name: MJA Jonge de

• Name: MJA Jonge de

Key inclusion & exclusion criteria

Inclusion criteria: 1. Cytologically or histologically proven SCLC;

2. Disease confined to one hemithorax without evidence of cytologically proven malignant pleural effusion;

3. No prior chemotherapy and/or radiotherapy;

4. Age 18 years or older;

5. Performance score 0 or 1;

6. Adequate organ functions (WBC > 3.0 x 10^9/L, ANC > 1.5 x 10^9/L, platelets > 100 x 10^9/L, serum creatinine < 135 mmol/L or creatinine clearance according to Cockroft-Gault formula > 60 ml/min, bilirubin < 1.25 ULN, AST/ALT < 2.5 ULN and LDH < 1.25 ULN);

7. Adequate pulmonary function (FEV1 > 30% of predicted, DLCO > 40% of predicted);

8. No prior malignancy unless 5 years in complete remission except for patients with prior breast cancer or melanoma. Patients with adequately treated basocellular carcinoma of the skin or cervical cancer are eligible;

9. Written informed consent.

Exclusion criteria: 1. Other serious ilnesses;

2. Concurrent therapy with other anti-cancer drugs;

3. Pregnancy or lactation;

4. Presence of diarrhoea;

5. Presence of suspicion of bowel obstruction or chronic inflammatory bowel disease.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Small cell lung cancer (SCLC)

Intervention(s)

Patients were treated at day 1 of three-weekly cycles 1 and 4 with irinotecan and cisplatin (340 mg and 135 mg, respectively).

A dose-escalation schedule of irinotecan (100/120/140/150 mg) and cisplatin (100 mg) at day 1 of cycles 2 and 3 with concurrent thoracic radiotherapy (total dose 45 Gy) was performed. At each dose level 3 patients were included.

Dose-limiting toxicity (DLT) was defined as one patient in any cohort having any of the following toxicities during cycle 2 and 3 (with concurrent thoracic radiotherapy), grade III/IV non-haematological toxicity despite adequate medication (excluding grade III/IV nausea and vomiting), grade IV neutropenia lasting for more than five days or complicated by fever and/or platelets < 25 x 10^9/L, or grade IV oesophagitis or grade III oesophagitis lasting for more than two weeks.
Maximum tolerated dose (MTD) was defined as two or more patients in any cohort experiencing DLT.

Primary Outcome(s)

The aim of the study is to determine the dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD) of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with LD-SCLC ias a onve every three weeks schedule.

Secondary Outcome(s)

To determine the efficacy and progression-free and overall survival of irinotecan and cisplatin with concurrent thoracic radiotherapy in patients with LD-SCLC.

Secondary ID(s)

ISRCTN75771514

Source(s) of Monetary Support

Aventis Pharma, The Netherlands