Title:
A Phase 1/2 Study to Assess the Safety and Efficacy of Lorvotuzumab Mertansine (IMGN901) in Combination with Carboplatin/Etoposide in Patients with Advanced Solid Tumors including Extensive Stage Small Cell Lung Cancer
Protocol Number:
J11100
Phase:
Phase I/II
Physician:
Christine Hann
Purpose:
Phase 1: To determine the maximum tolerated dose (MTD); characterize the dose limiting toxicities of IMGN901 when administered in combination with carboplatin/etoposide in patients with solid tumors. Assess any preliminary anti-tumor response, immune response, tolerability of the combined therapy in solid tumor patients. Phase 2: To determine the efficacy, tolerability and safety of IMGN901 in combination with carboplatin/etoposide first-line treatment for patients with extensive stage small cell lung cancer.
Eligibility:
Phase 1 patients with advanced solid tumors that carboplatin/etoposide would be reasonable treatment. No greater than 3 prior regimens. Phase 2- is a randomized trial for chemotherapy-naïve patients with confirmed, extensive small cell lung with measurable disease. All patients require normal organ and blood functions (including lipase and amylase), may not have uncontrolled hypertension, untreated brain metastases, or significant neurotoxicity. Anticoagulants may not be allowed.
Treatment:
Phase 1: Carboplatin on Day 1 only. Etoposide infused on days 1, 2 and 3. IMGN901 will be infused after etoposide on day one and repeated on day 8 of the 21 day cycle. Combination therapy will continue for 4 and up to six cycles as tolerated. Patients with responding or stable disease and tolerating the treatment, may continue single-agent treatment with IMGN901 until disease progression. IMGN901 may continue on Days 1 and 8 of a 21 day cycle as maintenance therapy. Phase 2: Randomization one of two treatment arms.ARM 1: Carboplatin on Day 1 only. Etoposide infused on days 1, 2 and 3. IMGN901 will be infused after etoposide on day one and repeated on day 8 of the 21 day cycle. Combination therapy will continue for 4 and up to six cycles as tolerated. Patients with responding or stable disease and tolerating the treatment, may continue single-agent treatment with IMGN901 until disease progression. IMGN901 will continue on Days 1 and 8 of a 21 day cycle.ARM 2: Carboplatin on Day 1 only. Etoposide infused on days 1, 2 and 3. Each cycle is 21 days. Treatment will be up to 6 cycles as tolerated.
Population:
Adult
Last Update
06/19/2013 04:02 AM
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