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Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01) (ABX067)

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Abraxane

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colon Cancer, Abraxis Oncology, Abraxane, Phase II, Colorectal, Mt. Sinai Medical Center, CCOP

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed written informed consent
Patients with histologically or cytologically confirmed stage IV colorectal cancer who have failed either irinotecan-based, oxaliplatin-based or both. ECOG performance status of 0-2
Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination
At least 3 weeks since last major surgery.
At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected. Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields.
At least 4 weeks since prior chemotherapy.
Pt with reproductive potential must use effective BC
Required Screening Laboratory Criteria:
- Hemoglobin 9.0g/dL
- WBC 3,500/mm3 [ 3.5 x 109/L]
- Neutrophils 1,500/mm3 [1.5 x 109/L]
- Platelets 100,000/mm3 [ 100.0 x 109/L]
- Creatinine 1.5 mg/dL (133 micromol/L) AND creatinine clearance 60 mL/min
A probable life expectancy of at least 6 months

Exclusion Criteria:

No brain metastases.
If female of childbearing potential, pregnancy test is negative.
Concomitant malignancies or previous malignancies other than colorectal cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer.
Active infection.
Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk.
Sexually active patients refusing to practice adequate contraception. (condom plus spermicide, or other form of birth control)
Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) should be excluded unless discussed and agreed with the principal investigator
History of grade 3 or 4 toxicity to fluoropyrimidines.
Pre-existing neuropathy ≥ NCI CTC grade 2.

Sites / Locations

Mount Sinai Medical Center

Outcomes

Primary Outcome Measures

To evaluate the efficacy by means of response rate of Abraxane and capecitabine in combination, in the treatment of patients with colorectal cancer in the 2nd or 3rd line metastatic setting following failure of irinotecan or oxaliplatin based therapy

Secondary Outcome Measures

To evaluate overall survival, time to progression, response duration, time to response and safety of this combination

Full Information

NCT ID

NCT00625573

First Posted

February 19, 2008

Last Updated

September 17, 2009

Sponsor

Mt. Sinai Medical Center, Miami

Collaborators

Celgene Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00625573

Brief Title

Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01)

Acronym

ABX067

Official Title

Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mt. Sinai Medical Center, Miami

Collaborators

Celgene Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is an open-label, phase II study to evaluate the efficacy and safety of Abraxane in combination with Capecitabine in patients with metastatic colorectal cancer in the second or third line

Detailed Description

Inclusion Criteria Signed written informed consent Patients with histologically or cytologically confirmed stage IV colorectal cancer who have failed either irinotecan-based, oxaliplatin-based or both. ECOG performance status of 0-2 Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination At least 3 weeks since last major surgery. At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected. Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields. At least 4 weeks since prior chemotherapy. Pt with reproductive potential must use effective BC Required Screening Laboratory Criteria: Hemoglobin 9.0g/dL WBC 3,500/mm3 [ 3.5 x 109/L] Neutrophils 1,500/mm3 [1.5 x 109/L] Platelets 100,000/mm3 [ 100.0 x 109/L] Creatinine 1.5 mg/dL (133 micromol/L) AND creatinine clearance 60 mL/min • A probable life expectancy of at least 6 months. Exclusion Criteria No brain metastases. If female of childbearing potential, pregnancy test is negative. Concomitant malignancies or previous malignancies other than colorectal cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer. Active infection. Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk. Sexually active patients refusing to practice adequate contraception. (condom plus spermicide, or other form of birth control) Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) should be excluded unless discussed and agreed with the principal investigator History of grade 3 or 4 toxicity to fluoropyrimidines. Pre-existing neuropathy ≥ NCI CTC grade 2

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

Colon Cancer, Abraxis Oncology, Abraxane, Phase II, Colorectal, Mt. Sinai Medical Center, CCOP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

29 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Abraxane

Intervention Description

100mg/m2 every week X's 3

Primary Outcome Measure Information:

Title

Time Frame

One year

Secondary Outcome Measure Information:

Title

To evaluate overall survival, time to progression, response duration, time to response and safety of this combination

Time Frame

One Year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed written informed consent Patients with histologically or cytologically confirmed stage IV colorectal cancer who have failed either irinotecan-based, oxaliplatin-based or both. ECOG performance status of 0-2 Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination At least 3 weeks since last major surgery. At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected. Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields. At least 4 weeks since prior chemotherapy. Pt with reproductive potential must use effective BC Required Screening Laboratory Criteria: Hemoglobin 9.0g/dL WBC 3,500/mm3 [ 3.5 x 109/L] Neutrophils 1,500/mm3 [1.5 x 109/L] Platelets 100,000/mm3 [ 100.0 x 109/L] Creatinine 1.5 mg/dL (133 micromol/L) AND creatinine clearance 60 mL/min A probable life expectancy of at least 6 months Exclusion Criteria: No brain metastases. If female of childbearing potential, pregnancy test is negative. Concomitant malignancies or previous malignancies other than colorectal cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer. Active infection. Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk. Sexually active patients refusing to practice adequate contraception. (condom plus spermicide, or other form of birth control) Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) should be excluded unless discussed and agreed with the principal investigator History of grade 3 or 4 toxicity to fluoropyrimidines. Pre-existing neuropathy ≥ NCI CTC grade 2.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Pizzolato, MD

Organizational Affiliation

Mt. Sinai Medical Center Miami Beach Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Sinai Medical Center

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33140

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01)

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