At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed adenocarcinoma of the pancreas with metastases not amenable to curative surgery or definitive radiation
- ✓Measurable advanced metastatic disease per RECIST criteria
- ✓ECOG performance status ≤2
- ✓Age ≥18 years
- ✕Prior systemic therapy for metastatic adenocarcinoma, except adjuvant gemcitabine/5-FU as radiosensitizer
- ✕Brain or leptomeningeal disease
- ✕Peripheral neuropathy grade ≥2
- ✕Chronic HIV, HBV, or HCV infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Lenalidomide in Combination With Gemcitabine in Subjects With Untreated Advanced Carcinoma of the Pancreas
In Brief
A Phase 2 clinical trial evaluating Lenalidomide and Gemcitabine for Metastatic Pancreatic Cancer. Completed, enrolled 72 participants across 9 sites.
Detailed Summary
To evaluate the 6-month overall survival, safety, and tolerability of lenalidomide in combination with standard gemcitabine as first-line treatment for patients with metastatic pancreatic cancer.
Study Details
Timeline
Interventions
The starting dose of lenalidomide for the lead-in portion will be 25 mg orally daily on Days 1-21, followed by a 7-day rest period (28-day cycle). If the 25-mg dose of lenalidomide is found to be intolerable or unsafe (i.e., if more than one of the 6 patients experience a DLT), then the dose will be reduced to 20 mg orally daily, and 6 additional patients will be treated. All patients will receive lenalidomide at the confirmed tolerable dose (either 25 mg or 20 mg given orally daily on Days 1-21 of a 28-day cycle) until disease progression. If the 20-mg daily dose is found to be intolerable or unsafe, enrollment will be put on hold.
Gemcitabine 1000 mg/m2 IV will be administered on Days 1, 8, and 15 for a 28-day cycle.