Clinical trial · Interventional
S0030: Capecitabine in Treating Older Patients W/Metastatic or Recurrent Colorectal Cancer That Cannot Be Surgically Removed
Protocol For Assessment Of Capecitabine For Advanced Colorectal Cancer In Patients Aged 70 Years And Older (And In A Cohort Of Patients Younger Than 60 Years)
NCT00049335CI-TRIAL-00008769completedPhase 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: Phase II trial to study the effectiveness of capecitabine in treating older patients who have metastatic or recurrent colorectal cancer that cannot be surgically removed.
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 |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capecitabine
- description
- Capecitabine 1,000 mg/m\^2/dose (2,000 mg/m\^2/day) BID, PO, Days 1-14 of 21 day cycle.
- interventionNames
- Drug: capecitabine
Primary outcomes (1)
- measure
- Feasibility of enrolling patients aged 70 years or older to a Phase II trial including pharmacokinetic sampling
- timeFrame
- Registration
Secondary outcomes (5)
- measure
- Efficacy of capecitabine for management of advanced colorectal cancer patients aged 70 years or older based on objective response rate and 2 year survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic or recurrent colorectal cancer not amenable to surgical resection * Measurable disease * No known brain metastases by MRI or CT scan PATIENT CHARACTERISTICS: Age * 70 and over OR * 18 to 59 Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Absolute granulocyte count at least 1,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 2 times upper limit of normal (ULN) * SGOT (serum glutamate oxaloacetate transaminase) or SGPT (serum glutamate pyruvate transaminase) no greater than 2 times ULN Renal * Creatinine no greater than 2 times ULN * Creatinine clearance greater than 50 mL/min Other * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No known seizure disorder * No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer currently in complete remission, or any other cancer for which the patient has been disease free for 5 years PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for advanced cancer * Prior adjuvant chemotherapy allowed provided recurrence occurred more than 1 year after the last treatment Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * At least 4 weeks since prior sorivudine or brivudine * No concurrent sorivudine or brivudine
References
Publications (0)
Data not yet available
No reference posted for this study.