Modulation of Autophagy in Patients With Advanced/Recurrent Non-small Cell Lung Cancer - Phase II
This study is currently recruiting participants.
Verified July 2012 by University of Medicine and Dentistry New Jersey
Sponsor:
University of Medicine and Dentistry New Jersey
Collaborator:
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT01649947
First received: July 20, 2012
Last updated: July 24, 2012
Last verified: July 2012
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Purpose
The purpose of this study is to examine the combination of one standard treatment for lung cancer plus an additional drug, hydroxychloroquine. The standard treatment for lung cancer being used includes 2 chemotherapy drugs, called paclitaxel and carboplatin. Some patients who have a specific type of lung cancer can also receive another drug, a drug that targets blood vessels, called bevacizumab (also known as avastin). Hydroxychloroquine is an FDA approved drug for the treatment of malaria, rheumatoid arthritis and lupus erythematosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer Recurrent Non-small Cell Lung Cancer |
Drug: Paclitaxel Drug: Carboplatin Drug: Hydroxychloroquine Drug: Bevacizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Modulation of Autophagy With Hydroxychloroquine in Patients With Advanced/Recurrent Non-small Cell Lung Cancer - a Phase II Study. A Study of The Cancer Institute of New Jersey Oncology Group (CINJOG) |
Resource links provided by NLM:
Drug Information available for:
Hydroxychloroquine
Hydroxychloroquine sulfate
Paclitaxel
Carboplatin
Bevacizumab
U.S. FDA Resources
Further study details as provided by University of Medicine and Dentistry New Jersey:
Primary Outcome Measures:
- Efficacy [ Time Frame: 15 months ] [ Designated as safety issue: No ]The primary objective of this study is to assess the antitumor activity, as measured by tumor response rate, of paclitaxel, carboplatin, Bevacizumab (for eligible patients) and hydroxychloroquine in patients with advanced or recurrent NSCLC cancer.
Secondary Outcome Measures:
- Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]1.2.1 To measure time to progression, percent one-year survival and overall survival
- Number of subjects with adverse events [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 17 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bevacizumab ineligible patients
Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Hydroxychloroquine 200 mg PO BID
|
Drug: Paclitaxel Drug: Carboplatin Drug: Hydroxychloroquine |
|
Experimental: Bevacizumab eligible patients
Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for Hydroxychloroquine 200 mg PO BID
|
Drug: Paclitaxel Drug: Carboplatin Drug: Hydroxychloroquine Drug: Bevacizumab |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
A patient is eligible for enrollment if all of the following inclusion criteria are met:
- Signed a protocol-specific informed consent.
- 18 years of age or older.
- ECOG Performance Status 0 or 1. (see Appendix A)
Cancer criteria:
- Histologically or cytologically confirmed non-small cell lung cancer. Mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible. Cytologic or histologic elements can be established on metastatic tumor aspirate or biopsy. Sputum cytology alone is not sufficient.
- Advanced stage NSCLC (stage IVa ((malignant pleural effusion (is now staged as stage IVa by the most recent staging system), or stage IV, or recurrent disease)).
- Measurable disease according to RECIST criteria.
- Patient with CNS metastasis are required to have stable disease documented by being off treatment (surgery, radiation therapy) for at least 2 weeks, and four (4) weeks is preferred. A contrast enhanced brain CT or brain MRI is required within 35 days of enrollment. Patients with brain metastases who qualify for protocol therapy will be included in Cohort 2 (ineligible for treatment with Bevacizumab).
- No prior cytotoxic chemotherapy or targeted therapy in the advanced or metastatic setting. Post-operative adjuvant therapy for previously resected NSCLC is allowed as long as the last dose was given greater than 1 year before study entry, and there is current evidence of disease progression.
- Prior radiation to sites other than the brain is allowed, if completed at least 2 weeks before treatment and provided that all radiation-related toxicities have resolved to ≤ Grade 1.
- No active malignancy other than NSCLC. Patients with a history of basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, or ductal or lobular carcinoma in situ of the breast within the past 3 years must have been treated with curative intent. Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for > 3 years.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649947
Contacts
| Contact: Office of Human Research Services | 732-235-8675 |
Locations
| United States, New Jersey | |
| The Cancer Institute of New Jersey | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Office of Human Research Services 732-235-8675 | |
| Principal Investigator: Joseph Aisner, MD | |
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
| Principal Investigator: | Joseph Aisner, MD | University of Medicine and Dentistry New Jersey |
More Information
No publications provided
| Responsible Party: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT01649947 History of Changes |
| Other Study ID Numbers: | 031105, 0220110249, P30CA072720 |
| Study First Received: | July 20, 2012 |
| Last Updated: | July 24, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Hydroxychloroquine Bevacizumab Carboplatin Paclitaxel Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic Angiogenesis Inhibitors Angiogenesis Modulating Agents |
ClinicalTrials.gov processed this record on May 23, 2013