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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23572

Enrollment

Registered

2007-03-20

Start date

2003-01-06

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Limited-disease small cell lung cancer (LD-SCLC).

Interventions

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 cispla

Eligibility

Inclusion 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 60 ml/min, bilirubin 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

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.

Design outcomes

Primary

Measure	Time frame
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

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

Contacts

Public ContactMJA Jonge de

Erasmus University Medical Center / Daniel den Hoed Kliniek Department of Medical Oncology P.O. Box 5201

m.dejonge@erasmusmc.nl+31 10 4391 760

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)