Clinical trial · Interventional
Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer
A Phase II Study Of PS-341 In Patients With Metastatic Colorectal Cancer
NCT00052507CI-TRIAL-00018624completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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: Bortezomib may interfere with the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have metastatic or recurrent colorectal cancer.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is incurable with conventional therapy * Metastatic or recurrent disease * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques or at least 10 mm by spiral CT scan * Disease must be accessible to biopsy * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 OR * Karnofsky 70-100% Life expectancy * More than 3 months Hematopoietic * Absolute granulocyte count at least 1,500/mm\^3 * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.25 times upper limit of normal (ULN) * AST or ALT no greater than 3 times ULN (less than 5 times ULN if liver metastases present) Renal * Creatinine no greater than 1.25 times UNL OR * Creatinine clearance at least 50 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled concurrent illness * No ongoing or active infection * No other active malignancy within the past 3 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No grade 1 or greater peripheral neuropathy due to prior chemotherapy * No significant traumatic injury within the past 21 days PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No more than 1 line of prior chemotherapy (including any combination of fluorouracil, irinotecan, and/or oxaliplatin) for metastatic disease * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * Prior adjuvant chemotherapy allowed * No concurrent cytotoxic chemotherapy Radiotherapy * More than 4 weeks since prior radiotherapy and recovered * No prior radiotherapy to measurable target lesion unless disease progression has occurred after radiotherapy * No concurrent radiotherapy to the sole site of measurable disease Surgery * More than 21 days since prior major surgery Other * No other concurrent investigational agents * No concurrent combination antiretroviral therapy for HIV-positive patients
References
Publications (1)
- RESULTMackay H, Hedley D, Major P, Townsley C, Mackenzie M, Vincent M, Degendorfer P, Tsao MS, Nicklee T, Birle D, Wright J, Siu L, Moore M, Oza A. A phase II trial with pharmacodynamic endpoints of the proteasome inhibitor bortezomib in patients with metastatic colorectal cancer. Clin Cancer Res. 2005 Aug 1;11(15):5526-33. doi: 10.1158/1078-0432.CCR-05-0081. PMID 16061869