Clinical trial · Interventional
Lenalidomide and Docetaxel in Treating Patients With Advanced Solid Tumors
Phase I Trial of Daily Lenalidomide (CC-5013, Revlimid™) and Docetaxel Given Every Three Weeks in Patients With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with docetaxel may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when given together with docetaxel in treating patients with advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose
- timeFrame
- measured at end of phase I
- measure
- Dose-limiting toxicity
- timeFrame
- measured after every course
Secondary outcomes (1)
- measure
- Disease response
- timeFrame
- measured after every 2 courses
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor * Advanced disease * Refractory to standard therapy OR no standard therapy exists * Measurable or evaluable disease * No active brain metastases * Previously treated (e.g., surgery or radiotherapy) brain metastases are allowed provided they are currently asymptomatic and inactive by CT scan or MRI PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * At least 4 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8 g/dL Hepatic * Bilirubin normal * Meets 1 of the following criteria: * Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN) * AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN * AP ≤ 5 times ULN AND AST or ALT normal Renal * Creatinine ≤ 2 mg/dL Cardiovascular * No New York Heart Association class III or IV heart disease Immunologic * No prior desquamating rash or ≥ grade 2 allergic reaction while receiving thalidomide * No history of hypersensitivity to docetaxel or other drugs formulated in polysorbate 80 * No history of allergic reaction to compounds of similar chemical or biologic composition to study drugs Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other uncontrolled illness or other condition that would preclude study compliance * No peripheral neuropathy ≥ grade 2 PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent hematopoietic growth factors during course 1 of study treatment * No concurrent immunotherapy Chemotherapy * At least 6 weeks since prior mitomycin or nitrosoureas * No more than 2 prior courses of mitomycin * No other concurrent chemotherapy Radiotherapy * No prior pelvic radiotherapy Other * At least 4 weeks since prior anticancer therapy * No concurrent warfarin for anticoagulation (heparin is allowed) * Recovered from all prior treatment * No other concurrent anticancer therapy except bisphosphonates * No other concurrent investigational agents
References
Publications (1)
- RESULTSanborn SL, Gibbons J, Krishnamurthi S, Brell JM, Dowlati A, Bokar JA, Nock C, Horvath N, Bako J, Remick SC, Cooney MM. Phase I trial of docetaxel given every 3 weeks and daily lenalidomide in patients with advanced solid tumors. Invest New Drugs. 2009 Oct;27(5):453-60. doi: 10.1007/s10637-008-9200-x. Epub 2008 Nov 15. PMID 19011760