Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Metastatic Colon Cancer

Colorectal Cancer Clinical Trial

Official title:

Phase II Study of Oxaliplatin And Fixed Rate Infusion Gemcitabine as Second Line Therapy for Patients With Metastatic Colon Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00276861
• Other study ID #: UMIAMI-20030655
• Secondary ID: SCCC-2003110WIRB
• Status: Terminated
• Phase: Phase 2
• First received: January 12, 2006
• Last updated: July 25, 2014
• Start date: September 2005
• Est. completion date: May 2008

Study information

• Verified date: August 2013
• Source: University of Miami Sylvester Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 2008
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Drug:
• gemcitabine hydrochloride

• oxaliplatin

Locations

Country	Name	City	State
United States	University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami Sylvester Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lopes 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 poo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate as Measured by RECIST Criteria	Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.	4 - 6 months	No
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.	6 months	No