Clinical trial · Interventional
Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Metastatic Colon Cancer
Phase II Study of Oxaliplatin And Fixed Rate Infusion Gemcitabine as Second Line Therapy for Patients With Metastatic Colon Cancer
NCT00276861CI-TRIAL-00025851terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low Accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works as second-line therapy in treating patients with metastatic or recurrent colon 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response Rate as Measured by RECIST Criteria
- timeFrame
- 4 - 6 months
- description
- Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.
Secondary outcomes (1)
- measure
- Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment
- timeFrame
- 6 months
- description
- Number of months from time of enrollment to the date of first documented progression or date of death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the colon * Metastatic or recurrent disease * Redocumentation of tumor histology or cytology prior to protocol therapy is not required if documented tumor was confirmed prior to initial therapy * Measurable disease * Lesion of ≥ 1 cm in longest diameter that can be repetitively assessed by radiographic measurement or any lesion of ≥ 2 cm in longest diameter that can be repetitively assessed by physical examination * Positive bone scans, osteoblastic or osteolytic bone lesions, pleural effusions, and positive bone marrow biopsies are not considered measurable or evaluable lesions * Metastatic disease to the brain allowed if emergent radiotherapy for symptomatic CNS disease is not required * Must have received at least one prior chemotherapy regimen (with or without radiotherapy) * One of the prior regimens must include irinotecan hydrochloride, fluorouracil, and leucovorin calcium or irinotecan hydrochloride and other fluoropyrimidine * Previous therapy with C-225 and/or bevacizumab is allowed * . PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Granulocyte count ≥1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine ≤ 2.0 mg/dL * Bilirubin \< 1.5 mg/dL * SGOT ≤ 2 times upper limit of normal (ULN) * Alkaline phosphatase \< 2.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No serious medical or psychiatric illness that would render chemotherapy unsafe * No concurrent clinically evident malignancy except inactive nonmelanoma skin cancer, low-grade low-stage bladder carcinoma followed off therapy, or lobular neoplasia of the breast * No clinical AIDS or known positive HIV serology PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior therapy * No investigational agent for at least 30 days prior to study entry * No chemotherapy within the past 3 weeks * No radiotherapy for palliation within the past 2 weeks prior to study entry * No prior oxaliplatin or gemcitabine hydrochloride * No concurrent participation in another clinical trial * No other concurrent anticancer therapy including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy * No other concurrent investigational drugs
References
Publications (1)
- RESULTLopes G, Quesada J, Ahn E, Flores A, Ribeiro A, Rocha-Lima CM. Oxaliplatin and fixed-rate infusional gemcitabine in the second-line treatment of patients with metastatic colon cancer: final results of a Phase II trial prematurely closed as a result of poor accrual. Clin Colorectal Cancer. 2007 Sep;6(9):641-5. doi: 10.3816/CCC.2007.n.032. PMID 17945036