Clinical trial · Interventional
Ro 31-7453 in Treating Patients With Recurrent or Refractory Metastatic Colorectal Cancer
A Randomized Phase II Study of Two Shcedules of Ro 31-7453 in Patients With Metastatic (Dukes' D) Colorectal Carcinoma (CRC) Who Have Failed Both Fluoropyrimidine and Irinotecan Chemotherapy
NCT00016250CI-TRIAL-00010746completedPhase 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of Ro 31-7453 in treating patients who have recurrent or refractory metastatic 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 |
|---|---|---|---|
| MKC-1 | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic adenocarcinoma of the colon or rectum * Bidimensionally measurable disease * At least 2.0 x 2.0 cm * Failed prior fluoropyrimidine and irinotecan chemotherapy in adjuvant or metastatic setting * Must have had disease progression while receiving chemotherapy OR * If received fluorouracil with or without irinotecan in adjuvant setting, must also have failed therapy with these agents in metastatic setting (unless manifesting metastatic disease during adjuvant therapy) * No known CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * Hemoglobin at least 9 g/dL * Absolute neutrophil 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 1.5 times upper limit of normal (ULN) * AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present) * Alkaline phosphatase no greater than 2.5 ULN (5 times ULN if bone or liver metastases present) Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No New York Heart Association class III or IV congestive heart failure * No myocardial infarction within the past 6 months Gastrointestinal: * No bowel obstruction * No active uncontrolled malabsorption syndrome Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection * No other prior malignancy within the past 5 years except carcinoma in situ of the cervix or non-melanoma skin cancer * No other active cancers, including stable disease on adjuvant therapy * No other medical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * See Chemotherapy * At least 2 weeks since prior biologic therapy and recovered Chemotherapy: * See Disease Characteristics * No more than 2 prior cytotoxic chemotherapy regimens for metastatic disease * Monoclonal antibody (MOAB) therapy and antiangiogenic agents not included as prior cytotoxic chemotherapy * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: * Not specified Radiotherapy: * At least 3 weeks since prior radiotherapy and recovered Surgery: * No prior total gastrectomy Other: * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.