Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Irinotecan/Capecitabine Versus Capecitabine in Patients Treated With A/T for HER2 Negative Metastatic Breast Cancer (PROCEED)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by National Cancer Center, Korea.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Asan Medical Center
Chung-Ang University
Inha University Hospital
Korea University Anam Hospital
Samsung Medical Center
Severance Hospital
Seoul National University Hospital
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Jungsil Ro, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01501669
First received: December 27, 2011
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

This study is a multicenter, randomized study, open-label, phase III study.The efficacy of irinotecan and capecitabine combination will be superior to capecitabine alone in term of progression free survival in metastatic breast cancer patients previously treated with anthracycline and taxane.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Irinotecan, Capecitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Multicenter Randomized Open-label Study of Irinotecan Plus Capecitabine Versus Capecitabine in Patients Previously Treated With Anthracycline and Taxane for HER2 Negative Metastatic Breast Cancer[PROCEED]

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: The analysis for reporting the final treatment results will be undertaken when each patient has been potentially followed for a minimum of 12 months ] [ Designated as safety issue: No ]
    Day between the date of enrollment to the date of disease progression or death


Secondary Outcome Measures:
  • Objective response rate Overall survival (OS) Toxicity Quality of life (QoL) Pharmacogenomic study of irinotecan and capecitabine [ Time Frame: The analysis for reporting the final treatment results will be undertaken when each patient has been potentially followed for a minimum of 12 months ] [ Designated as safety issue: Yes ]
    Objective response rate Overall survival (OS) Toxicity Quality of life (QoL) Pharmacogenomic study of irinotecan and capecitabine


Estimated Enrollment: 222
Study Start Date: June 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Capecitabine alone arm
X arm
Experimental: Irinotecan plus capecitabine arm Drug: Irinotecan, Capecitabine

Irinotecan 80 mg/m2, day 1 and 8, every 3 weeks

+ capecitabine 1000 mg/m2, BID, day 1-14, every 3 weeks

Other Name: IX arm

Detailed Description:

Prior to enrollment, patients will be confirmed for hormone and HER2 receptor status. Patients may have either measurable and/or evaluable metastatic lesions which are able to be assessed by chest, abdomen CT and bone scan performed within 28 days prior to start of treatment.

  • Capecitabine alone arm: 1250 mg/m2, BID, day 1-14, every 3 weeks
  • Irinotecan plus capecitabine arm : Irinotecan 80 mg/m2, day 1 and 8, every 3 weeks + capecitabine 1000 mg/m2, BID, day 1-14, every 3 weeks.

Randomization will be done using a random block size permutation method and stratified based on : hormone receptor status (negative vs. positive), first line vs. more than second lines, visceral metastasis (negative vs. positive).

Treatment will continue until disease progression, death, or discontinuation due to side effects of drugs or refusal by patients.

The primary objective of this study is to estimate the PFS of capecitabine and irinotecan in patients with anthracycline and taxane- pretreated metastatic breast cancer, which will be estimated by the Kaplan-Meier method and compared by log-rank test. Overall survival will be also estimated by same method. The secondary statistical analysis consisting of an estimation of the complete and partial response rates and response rates of the treatment will be calculated as the ratio of the number of complete and partial responders to the total number of evaluable patients and toxicity profile, which will be estimated as the ratio of the number of occurrence to the total number of evaluable patients. A 95% confidence interval for the response rate is computed based on the binomial distribution function. The analysis for reporting the final treatment results will be undertaken when each patient has been potentially followed for a minimum of 12 months. The overall survival and progression free survival, and their respective medians will be estimated with 95% confidence intervals.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed stage IV or recurrent breast cancer
  • HER2 negative disease, or HER2 unknown disease not eligible for anti-HER2 therapy
  • ECOG performance status 0-2
  • Age ≥ 20 years
  • Patients who received anthracycline based chemotherapy in the (neo)adjuvant or metastatic setting and experienced disease progression on taxane based chemotherapy in the metastatic setting, or patients who experienced disease recurrence within 1 year after completion of (neo)adjuvant anthracycline and taxane based chemotherapy
  • In case of patients treated with capecitabine in an adjuvant setting, disease recurrence should not be occurred within 1 year after completion of capecitabine chemotherapy
  • Patients with brain metastasis can be enrolled when they don't need any treatment regarding to brain metastasis
  • Previous any chemotherapy and radiotherapy should be completed at least 3 weeks before randomization- Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [21]
  • Adequate hematopoietic function: absolute granulocyte count ≥ 1,500/mm3, platelet ≥ 100,000/mm3, hemoglobin ≥ 10g/mm3
  • Adequate hepatic function: total bilirubin ≤ 1.5mg/dL, alkaline phosphatase(ALP) ≤ 2.5 x UNL, AST/ALT ≤ 2x UNL, or if liver function abnormalities due to underlying malignancy exists, AST/ALT ≤ 2.5 x UNL, total bilirubin ≤ 3.0mg/dL, (ALP) ≤ 5 x UNL in cases with bone metastasis; ALP ≤ 5 x UNL
  • Adequate renal function : serum creatinine ≤ 1.5mg/dL
  • Ability to understand and comply with protocol during study period
  • Patients should sign a written informed consent before study entry

Exclusion Criteria:

  • Pregnant or lactating women
  • Patients who receive irinotecan or capecitabine for metastatic breast cancer treatment
  • Patients with HER2 positive breast cancer
  • Grade 2 or greater peripheral neuropathy
  • Patients with symptomatic brain metastasis
  • Prior unanticipated severe reaction to fluropyrimidine therapy or known sensitivity to 5-fluorouracil
  • Patients who have history of cancer other than in situ cervical cancer or non-melanotic skin cancer
  • Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedure affecting absorption, uncontrolled GI disease (e.g. Crohn's disease, ulcerative colitis)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501669

Contacts
Contact: Jungsil Ro +82-31-920-1610 jungsro@ncc.re.kr
Contact: Inhae Park +82-31-920-1680 parkih@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of
Contact: Jungsil Ro    +82-31-920-1610    jungsro@ncc.re.kr   
Principal Investigator: Jungsil Ro         
Sponsors and Collaborators
National Cancer Center, Korea
Asan Medical Center
Chung-Ang University
Inha University Hospital
Korea University Anam Hospital
Samsung Medical Center
Severance Hospital
Seoul National University Hospital
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Jungsil Ro National Cencer Center, Korea
  More Information

No publications provided

Responsible Party: Jungsil Ro, Chief, Center for Clinical Trials, National Cancer Center, Korea, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01501669     History of Changes
Other Study ID Numbers: NCCCTS-11-536
Study First Received: December 27, 2011
Last Updated: July 17, 2012
Health Authority: South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by National Cancer Center, Korea:
irinotecan
capecitabine
metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Fluorouracil
Irinotecan
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014