Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced, Unresectable, or Metastatic Stomach Cancer

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00354224
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 43
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine 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 capecitabine together with oxaliplatin works in treating patients with locally advanced, unresectable, or metastatic stomach cancer.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: capecitabine; Drug: oxaliplatin	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Determine the response proportion in patients with locally advanced, unresectable, or metastatic gastric cancer treated with capecitabine and oxaliplatin.

Secondary

• Determine the tolerability and toxicity of this regimen in these patients.

• Determine the median and progression-free survival of patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-7. Treatment repeats every 14 days in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of XELOX in Locally Advanced or Metastatic Gastric Cancer
• Actual Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oxaliplatin + Capecitabine Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day.	Drug: capecitabine; Drug: oxaliplatin

Outcome Measures

Primary Outcome Measures

1. Response Rate as Determined by RECIST. [Every 6 weeks through study completion for up to about 18 weeks]

   Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Secondary Outcome Measures

1. Number of Adverse Events [From the start of study treatment through study completion for up to about 18 weeks]

2. Progression-free Survival [Every 6 weeks through study completion for up to about 18 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed gastric cancer

• Locally advanced, unresectable, or metastatic disease

• Measurable disease, defined as at least 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan

• No known brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%

• WBC ≥ 3,000/mm³

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Bilirubin normal

• AST/ALT ≤ 2.5 times upper limit of normal

• Creatinine ≤ 1.5 mg/dL

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during study and for 6 months after completion of study treatment

• Able to swallow

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to fluoropyrimidines or platinum chemotherapy agents

• No uncontrolled intercurrent illness including, but not limited to the following:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• Psychiatric illness or social situations that would preclude study compliance

PRIOR CONCURRENT THERAPY:

• More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered

• At least 6 months since prior radiotherapy with capecitabine as a radioenhancer

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent chemotherapy

• No concurrent palliative radiotherapy

• No concurrent hormonal therapy except for the following:

• Steroids for adrenal failure

• Hormones for nondisease related conditions (e.g., insulin for diabetes)

• Intermittent use of dexamethasone as an antiemetic

• No other concurrent investigational agents

• No other concurrent anticancer agents or therapies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Medical University of South Carolina

Investigators

• Study Chair: Uzair B. Chaudhary, MD, Medical University of South Carolina
• Study Chair: Gustavo Leone, Medical University of South Carolina, Hollings Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT00354224
• Other Study ID Numbers: MUSC-100829; MUSC-OX-33-064; MUSC-HR-11497; CDR0000484638
• First Posted: Jul 20, 2006
• Last Update Posted: Jul 16, 2018
• Last Verified: Jul 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Medical University of South Carolina: recurrent gastric cancer; stage III gastric cancer; stage IV gastric cancer
• Additional relevant MeSH terms: Stomach Neoplasms; Capecitabine; Oxaliplatin

Study Results

Participant Flow

Arm/Group Title	Oxaliplatin + Capecitabine
Arm/Group Description	Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day. capecitabine oxaliplatin
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Oxaliplatin + Capecitabine
Arm/Group Description	Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day. capecitabine oxaliplatin
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 20%
>=65 years	8 80%
Sex: Female, Male (Count of Participants)
Female	4 40%
Male	6 60%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	5 50%
White	5 50%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	Response Rate as Determined by RECIST.
Description	Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame	Every 6 weeks through study completion for up to about 18 weeks

Outcome Measure Data

Analysis Population Description

this data was not collected.

Arm/Group Title	Oxaliplatin + Capecitabine
Arm/Group Description	Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day. capecitabine oxaliplatin
Measure Participants	0

2. Secondary Outcome

Title	Number of Adverse Events
Time Frame	From the start of study treatment through study completion for up to about 18 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oxaliplatin + Capecitabine
Arm/Group Description	Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day. capecitabine oxaliplatin
Measure Participants	10
Number [Serious Adverse Events]	4

3. Secondary Outcome

Title	Progression-free Survival
Time Frame	Every 6 weeks through study completion for up to about 18 weeks

Outcome Measure Data

Analysis Population Description

data was not collected for this endpoint.

Arm/Group Title	Oxaliplatin + Capecitabine
Arm/Group Description	Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day. capecitabine oxaliplatin
Measure Participants	0

Adverse Events

Time Frame	From the start of study treatment through study completion for up to about 18 weeks
Adverse Event Reporting Description	data for non-serious adverse events was not collected.
Arm/Group Title	Oxaliplatin + Capecitabine
Arm/Group Description	Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day. capecitabine oxaliplatin
All Cause Mortality
	Oxaliplatin + Capecitabine
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Oxaliplatin + Capecitabine
	Affected / at Risk (%)	# Events
Total	4/10 (40%)
Cardiac disorders
supraventricular tachycardia	1/10 (10%)	1
angina	1/10 (10%)	1
General disorders
draining abdominal scar	1/10 (10%)	1
Skin and subcutaneous tissue disorders
cellulitis	1/10 (10%)	1
Other (Not Including Serious) Adverse Events
	Oxaliplatin + Capecitabine
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.