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A Pilot Study of PPX (Paclitaxel Poliglumex, CT-2103) in Women With Metastatic Colorectal Cancer

18 Years
Not Enrolling
Advanced Colorectal Cancer

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Trial Information

A Pilot Study of PPX (Paclitaxel Poliglumex, CT-2103) in Women With Metastatic Colorectal Cancer

Inclusion Criteria:

- Women with histologically confirmed metastatic adenocarcinoma of the colon or rectum.
The primary histologic diagnosis is sufficient if there is clear evidence by imaging
and/or markers of metastatic disease sites.

- Must have failed or are intolerant of or ineligible for CPT-11, 5-FU, oxaliplatin,
bevacizumab and either cetuximab or panitumumab therapies.

- Tumor must be accessible for biopsy or paraffin embedded tissue must be available for

- SWOG performance status 0-2.

- Estradiol levels >30 pg/mL **This may be supplemented by exogenous estrogen (by gel)

- AGC >1,500, platelets >100,000

- Total bilirubin < 3 x upper limit of normal, Transaminase (AST and/or ALT) < 2 x
upper limit of normal or < 5 x upper limit of normal in patients with liver

- Patients must have a creatinine of < 1.5 x upper limit of normal or a measured or
calculated creatinine clearance greater than 35 mL/min obtained within 7 days of
first receiving study drug.

- Except for cancer-related abnormalities, patients should not have unstable or
pre-existing major medical conditions.

- At least one measurable lesion according to the RECIST criteria which has not been
irradiated (i.e. newly arising lesions in previously irradiated areas are accepted).
Ascites, pleural effusion, and bone metastases are not considered measurable.
Minimum indicator lesion size: > 10 mm measured by spiral CT or > 20mm measured by
conventional techniques.

- Have a negative serum pregnancy test within 7 days prior to initiation of
chemotherapy (female patients of childbearing potential).

- Life expectancy > 3 months.

Exclusion Criteria:

- History of a malignancy other than colon or rectal cancer, except for adequately
treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other
cancer for which the patient has been disease-free for five years.

- Estradiol levels < 30 pg/mL, not responsive to supplementation.

- History of previous thromboembolic event, unless patient is on anticoagulation

- Grade 2 or greater neuropathy.

- Pregnant or lactating woman. Woman or men of childbearing potential not using a
reliable and appropriate contraceptive method (either a barrier or hormonal method is
acceptable). Patients must agree to continue contraception for 30 days from the date
of the last study drug administration. (Postmenopausal woman must have been
amenorrheic for at least 12 months to be considered of non-childbearing potential).

- Patients with known brain metastases, unless they are well controlled - i.e. on a
stable dose of steroids or if steroid therapy has been completed.

- Patients that have received experimental therapies or other approved bio- or
chemotherapies within 30 days of study entry.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

RECIST Response

Outcome Time Frame:

Assessed Every 6 Weeks Until Patient goes off Study

Safety Issue:


Principal Investigator

Syma Iqbal, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

U.S.C. / Norris Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2008

Completion Date:

September 2008

Related Keywords:

  • Advanced Colorectal Cancer
  • Colon Cancer Rectal Colorectal Women
  • Colorectal Neoplasms



University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center Los Angeles, California  90033