Clinical trial NCT00625573: Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01)
Official title: Phase II Trial of Abraxane and Capecitabine in Metastatic Colon Cancer (COL 01)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: Colon Cancer
Abraxis Oncology
Abraxane
Phase II
Colorectal
Mt. Sinai Medical Center
CCOP
Lead sponsor: Mt. Sinai Medical Center, Miami
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2008-02-28
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: 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
timeFrame: One year
Secondary outcomes:
measure: To evaluate overall survival, time to progression, response duration, time to response and safety of this combination
timeFrame: One Year
Other outcomes:
Locations:
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
Study officials:
affiliation: Mt. Sinai Medical Center Miami Beach Florida
name: Joseph Pizzolato, MD
role: PRINCIPAL_INVESTIGATOR
References: