Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I Study of OSI-774 (NSC 718781) for Solid Tumors in Patients With Hepatic or Renal Dysfunction
Phase I trial to study the effectiveness of erlotinib in treating patients who have metastatic or unresectable solid tumors and liver or kidney dysfunction. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of erlotinib in patients with solid tumors and
hepatic or renal dysfunction.
II. Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
hepatic or renal dysfunction (albumin less than 2.5 g/dL, direct bilirubin less than 1.0
mg/dL, any AST, and creatinine normal vs direct bilirubin 1.0-7.0 mg/dL, any AST, and
creatinine normal vs creatinine 2.5-5.0 mg/dL, albumin 2.5 g/dL or greater, AST less than 3
times upper limit of normal, and direct bilirubin less than 1.0 mg/dL).
Patients receive oral erlotinib once daily. Treatment continues in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at
least 6 evaluable patients are treated at that dose.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01828775 -
Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment
|
N/A | |
| Terminated |
NCT01642342 -
Recombinant Albumin Fusion Protein sEphB4-HSA in Treating Patients With Metastatic or Recurrent Solid Tumors
|
Phase 1 | |
| Completed |
NCT00002950 -
Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01705548 -
Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
|
N/A | |
| Completed |
NCT02146222 -
VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Docetaxel in Treating Patients With Solid Tumors
|
Phase 1 | |
| Terminated |
NCT01602627 -
Hsp90 Inhibitor AUY922 in Treating Older Patients With Advanced Solid Malignancies
|
Phase 1 | |
| Completed |
NCT01191216 -
1-Methyl-D-Tryptophan and Docetaxel in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT00992303 -
Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants
|
||
| Recruiting |
NCT01137825 -
Registry of Older Patients With Cancer
|
||
| Suspended |
NCT00935090 -
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
|
N/A | |
| Completed |
NCT00924651 -
Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
|
Phase 3 | |
| Completed |
NCT00949949 -
Everolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable Solid Tumors Refractory to Standard Therapy
|
Phase 1 | |
| Withdrawn |
NCT00937417 -
S0716 Vandetanib and Docetaxel in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT00710632 -
Screening to Predict Weight Loss in Patients With Cancer
|
N/A | |
| Completed |
NCT00573690 -
Sorafenib Combined With Cisplatin and Etoposide or Carboplatin and Pemetrexed in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT00544596 -
R-(-)-Gossypol Acetic Acid, Cisplatin, and Etoposide in Treating Patients With Advanced Solid Tumors or Extensive Stage Small Cell Lung Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT00436735 -
Nelfinavir in Treating Patients With Metastatic, Refractory, or Recurrent Solid Tumors
|
Phase 1 | |
| Completed |
NCT00352443 -
S0528 Lapatinib and Everolimus in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Completed |
NCT00255658 -
Sorafenib and Temsirolimus in Treating Patients With Unresectable or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT00128622 -
Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer
|
Phase 1 |