Chloroquine as an anti-autophagy drug in small cell lung cancer (SCLC) patients: A phase I trial to be followed by a phase II trial. - chloroquine in SCLC

• Conditions: To determine the toxicity of adding chloroquine in escalating doses in SCLC patients - to standard dose cisplatin-etoposide in extensive disease SCLC = STEP 1- to standard dose concurrent radiotherapy and cisplatin-etoposide in limited disease SCLC = STEP2; MedDRA version: 12.0Level: PTClassification code 10041068Term: Small cell lung cancer extensive stage; MedDRA version: 12.0Level: PTClassification code 10041069Term: Small cell lung cancer limited stage

• Registration Number: EUCTR2009-014772-22-NL
• Lead Sponsor: MAASTRO Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Fase I, Step 1: chloroquine added to standard dose cisplatin-etoposide in extensive disease SCLC.

1. Histologically or cytologically confirmed ``extensive disease`` (Stage T0-4 N0-3 M1) small cell lung cancer
2. At least one measurable disease site, defined as lesion of = 1 cm unidimensionally on CT-scan.
3. WHO performance status 0-2
4. Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and hemoglobin at least 6.2 mmol/l.
5. Calculated creatinine clearance at least 60 ml/min
6. Adequate hepatic function: Total bilirubin = 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase = 2.5 x ULN for the institution (in case of liver metastases = 5 x ULN for the institution)
7. No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.
8. Life expectancy more than 6 months
9. Willing and able to comply with the study prescriptions
10. 18 years or older
11. Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
12. Ability to give and having given written informed consent before patient registration
13. No mixed pathology, e.g. non-small cell plus small cell cancer

Fase I, Step 2: chloroquine added to standard dose cisplatin-etoposide plus radiotherapy in limited disease SCLC.
1. Histologically or cytologically confirmed `limited disease` ie stage T0-4 N0-3 M0 small cell lung cancer, excluding malignant pleural/pericardial effusion.
2. At least one measurable disease site, defined as lesion of = 1 cm unidimensionally on CT-scan.
3. WHO performance status 0-2
4. Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and hemoglobin at least 6.2 mmol/l.
5. Calculated creatinine clearance at least 60 ml/min
6. Adequate hepatic function: Total bilirubin = 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase = 2.5 x ULN for the institution (in case of liver metastases = 5 x ULN for the institution)
7. No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.
8. Life expectancy more than 6 months
9. Willing and able to comply with the study prescriptions
10. 18 years or older
11. Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
12. Ability to give and having given written informed consent before patient registration
13. No mixed pathology, e.g. non-small cell plus small cell cancer

Fase II, step 1:
1. Histologically or cytologically confirmed ``extensive disease`` (Stage T0-4 N0-3 M1) small cell lung cancer
2. At least one measurable disease site, defined as lesion of = 1 cm unidimensionally on CT-scan
3. WHO performance status 0-2
4. Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and hemoglobin at least 6.2 mmol/l.
5. Calculated creatinine clearance at least 60 ml/min
6. Adequate hepatic function: Total bilirubin = 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase = 2.5 x ULN for the institution (in case of liver metastases = 5 x ULN for the institution)
7. No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.
8. Life expectancy more than 6 months
9. Willing and able to comply with the study prescriptions
10. 18 years or older
11. Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
12. Ability to give and having given written informed consent before patient registra

Exclusion Criteria

the opposite of the above

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified