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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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00276861
Enrollment
10
Registered
2006-01-13
Start date
2005-09-30
Completion date
2008-05-31
Last updated
2017-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer

Brief summary

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.

Detailed description

OBJECTIVES: Primary * Determine the complete response and partial response rates in patients with recurrent or progressive colon cancer treated with gemcitabine hydrochloride and oxaliplatin. Secondary * Determine the overall and failure-free survival of patients treated with the chemotherapy regimen. * Determine the duration of response (complete or partial) in patients treated with this regimen. * Determine the percentage of patients who experience a 50% fall of serum carcinoembryonic antigen levels with a baseline elevation of \> 5 U/mL after receiving this regimen. * Evaluate the toxicity associated with the administration of this regimen in these patients. OUTLINE: This is a non-randomized study. Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 1 year. PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Interventions

DRUGgemcitabine hydrochloride
DRUGoxaliplatin

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Response Rate as Measured by RECIST Criteria4 - 6 monthsComplete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.

Secondary

MeasureTime frameDescription
Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment6 monthsNumber of months from time of enrollment to the date of first documented progression or date of death.

Countries

United States

Participant flow

Participants by arm

ArmCount
Single Arm10
Total10

Baseline characteristics

CharacteristicSingle Arm
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
3 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
Age, Continuous58.5 years
Gender
Female
2 Participants
Gender
Male
8 Participants
Region of Enrollment
United States
10 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
10 / 10
serious
Total, serious adverse events
2 / 10

Outcome results

Primary

Response Rate as Measured by RECIST Criteria

Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.

Time frame: 4 - 6 months

ArmMeasureValue (NUMBER)
Single ArmResponse Rate as Measured by RECIST Criteria9.9 percentage of particpants
Secondary

Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment

Number of months from time of enrollment to the date of first documented progression or date of death.

Time frame: 6 months

ArmMeasureValue (NUMBER)
Single ArmTime to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment4.6 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026