Colorectal Cancer Clinical Trial
Official title:
A Phase I Trial of Nelfinavir (Viracept®) in Adults With Solid Tumors
RATIONALE: Nelfinavir may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of nelfinavir in
treating patients with metastatic, refractory, or recurrent solid tumors.
Status | Active, not recruiting |
Enrollment | 45 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed* solid malignancy for which there is no known curative therapy - Relapsed disease OR failed to respond to standard therapy OR refused standard therapy in cases where no curative option exists NOTE: *An exception to histological confirmation will be allowed if no tissue is available for review, the presence of malignancy is documented in a pathology report from an outside institution, or a new biopsy is contraindicated because of safety. - Brain metastases allowed provided all of the following criteria are met: - Prior evaluation and appropriate counseling - Prior treatment by radiation oncology PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Life expectancy = 3 months - Absolute neutrophil count = 1,500/mm³ - Platelet count = 100,000/mm³ - Bilirubin < 1.5 times upper limit of normal (ULN) - AST and ALT = 2.5 times ULN - Creatinine < 1.5 times ULN - Not nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception - No myocardial infarction within the past 6 months - No uncontrolled intercurrent illness, including, but not limited to, any of the following: - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: - See Disease Characteristics - More than 28 days since prior chemotherapy or biologic therapy - No concurrent chemotherapy, biologic therapy, or radiotherapy - No concurrent hormonal methods of birth control - No concurrent CYP3A4 inhibitors, including any of the following: - Antiarrhythmics (e.g., amiodarone, quinidine) - Neuroleptics (e.g., pimozide) - Sedative or hypnotic agents (e.g., midazolam hydrochloride, triazolam) - Ergot derivatives (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine) - Hydroxymethyl glutaryl co-enzyme A (HMG-CoA) reductase inhibitors (e.g., lovastatin, simvastatin, atorvastatin) - Concurrent pravastatin and rovustatin allowed - Rifampin - Rifabutin - Felodipine - Nifedipine - Sildenafil - Hypericum perforatum (St. John's wort) - No other concurrent anticancer agents or therapies - No concurrent escalating doses of corticosteroids for other noncancerous medical conditions |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and toxicity | Yes | ||
Primary | Maximum tolerated dose | Yes | ||
Secondary | Pharmacokinetics | No | ||
Secondary | Correlation of CYP3A4 activity with nelfinavir mesylate levels | No | ||
Secondary | Clinical efficacy | No | ||
Secondary | Biological and clinical effects of nelfinavir mesylate at the cellular and molecular level | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Completed |
NCT00098787 -
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05425940 -
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
|
Phase 3 | |
Suspended |
NCT04595604 -
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
|
N/A | |
Completed |
NCT03414125 -
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
|
N/A | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT03874026 -
Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
N/A | |
Completed |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
N/A | |
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Recruiting |
NCT05568420 -
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
|
||
Recruiting |
NCT02972541 -
Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer
|
N/A | |
Completed |
NCT02876224 -
Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors
|
Phase 1 | |
Completed |
NCT01943500 -
Collection of Blood Specimens for Circulating Tumor Cell Analysis
|
N/A |