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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Genentech |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00604461 |
The purpose of this research study is to evaluate how effective the combination of Carboplatin, Bevacizumab (Avastin™) and, Pemetrexed (Alimta™) is in the treatment of patients with Malignant Pleural Mesothelioma (MPM). A combination of cisplatin and pemetrexed is considered standard for this disease and typically off protocol patients would receive cisplatin or carboplatin and pemetrexed as standard of care.
Primary:
Determine the Overall Survival (OS), (median survival(MS) and 1-yr survival (1-yr S)), in newly diagnosed patients with MPM who are treated with a regimen consisting of cisplatin, bevacizumab, and pemetrexed. Patients will be followed until death and survival curves will be generated. Response rates will be assessed.
Secondary:
The planned length of the study (first subject screened to last subject enrolled) is 24 months. The planned length of the entire study (enrollment period + the treatment period + a follow-up period of at least 12 months) is 36 months.
Condition | Intervention | Phase |
---|---|---|
Mesothelioma |
Drug: Carboplatin, Bevacizumab and Pemetrexed |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Trial of Carboplatin, Bevacizumab and Pemetrexed in the First-Line Treatment of Patients With Malignant Pleural Mesothelioma (MPM) |
Estimated Enrollment: | 48 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A, B: Experimental
A: Tiered Dose Escalation/Phase II Dose, B: Maintenance Therapy |
Drug: Carboplatin, Bevacizumab and Pemetrexed
Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m2 Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m2 Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m2 Chemotherapy will be given for two cycles after maximal response. Patients will be taken off study at the time of progression. If the patient has stable disease or better, as a response, then patient will be maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occurs first. CT scans will be done every 12 weeks during maintenance phase |
A blood sample will be taken to check the patient's blood and platelet counts before each Pemetrexed dose. Before each cycle, we will review the patient's medical history, give them a physical exam (including vital signs: blood pressure, heart rate, breathing rate, temperature), and check their weight, performance status and blood. The patient's tumor will be measured after every other cycle. The patient's urine will be tested before every other cycle with Bevacizumab.
Treatment Regimen: To ensure the safety, before initiating the phase II dose, we will have a brief phase I portion, where tiered dose escalation to the anticipated phase II dose will occur.
Tier I Carboplatin at AUC of 5 Bevacizumab 15 mg/Kg I.V. on day 1 Pemetrexed 500 mg/m2 on day 1 Every 21 days
Tier II (Target dose) Carboplatin at AUC of 6 Bevacizumab 15 mg/Kg I.V. on day 1 Pemetrexed 500 mg/m2 on day 1 Every 21 days
Tier (-1) Carboplatin at AUC of 4 Bevacizumab 15 mg/Kg I.V. on day 1 Pemetrexed 500 mg/m2 on day 1 Every 21 days
With each cycle, we will give the following:
Folic Acid 300 µg to 1 mg orally once daily starting day 1. B12 injections given subcutaneously any time between days -7 to 1 of the first cycle and then every 9 weeks.
Dexamethasone 4mb BID on day-1,0, and day +1
Patients will be enrolled in cohorts of three. If one of the three patients has a dose limiting toxicity (DLT) then three additional patients will be enrolled. If no DLTs occur then patients will be accrued in the next dose level. If two DLTs occur in a cohort of three patients or in an expanded cohort of 6 patients then that dose level will be called the Maximum Administered Dose (MAD). A dose level below will be called the MTD and will be the recommended dose for further phase II testing. Al three patients in a cohort must complete one full cycle, before proceeding to the next cohort.
DLT will be defined as grade 4 neutropenia, febrile neutropenia, and any grade 3 or 4 non-hematologic toxicity except for alopecia and nausea/vomiting/diarrhea without adequate prophylaxis. (CTC version 3.0).
No further dose escalation will be attempted beyond dose Tier 2. If there are no dose-limiting toxicities in dose Tier 2 then this will be considered the phase II dose. If there is a DLT in dose Tier 1 then we will enroll 3 patients in Tier -1 and if no further DLTs occur then Tier -1 will be the phase II dose.
When the patient goes off-study, they will have a physical exam, tumor measurements, and blood test evaluations.
Each study patient will be contacted every 3 months for the rest of their life. Information about any extra treatments they have received will be collected and recorded if they are taken off-study because their disease got worse. If they are taken off-study for any other reason, we will collect information on any extra anti-cancer treatments they have received for Malignant Pleural Mesothelioma (MPM).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Laboratory Values:
Contact: Melissa Joiner, R.N. | 813-745-1896 | melissa.joiner@moffitt.org |
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Principal Investigator: Roohi Ismail-Khan, M.D. | |
Principal Investigator: George Simon, M.D. | |
Sub-Investigator: Scott Antonia, M.D. | |
Sub-Investigator: Gerold Bepler, M.D. | |
Sub-Investigator: Alberto Chiappori, M.D. | |
Sub-Investigator: Lynn Coppage, M.D. | |
Sub-Investigator: Eric Haura, M.D. | |
Sub-Investigator: Todd Hazelton, M.D. | |
Sub-Investigator: Tawee Tanvetyanon, M.D. | |
Sub-Investigator: Charles Williams, M.D. |
Principal Investigator: | Roohi Ismail-Khan, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
Principal Investigator: | George Simon, M.D. | H. Lee Moffitt Cancer Center & Research Institutute |
Responsible Party: | H. Lee Moffitt Cancer Center & Research Institute ( Roohi Ismail-Khan, M.D. ) |
Study ID Numbers: | MCC-14896, USFIRB#105715, AVF3483s |
Study First Received: | January 17, 2008 |
Last Updated: | January 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00604461 |
Health Authority: | United States: Institutional Review Board |
Carboplatin Bevacizumab Avastin Pemetrexed Alimta |
Folic Acid Pemetrexed Mesothelioma Carboplatin |
Bevacizumab Adenoma Neoplasms, Glandular and Epithelial |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Enzyme Inhibitors Folic Acid Antagonists Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |