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Phase II Study of the Combination of Paclitaxel Poliglumex (CT-2103, Xyotax) and Pemetrexed (Alimta) for the Treatment of Patients With Advanced Non-small Cell Lung Cancer.


Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Non-small Cell Lung Cancer

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Trial Information

Phase II Study of the Combination of Paclitaxel Poliglumex (CT-2103, Xyotax) and Pemetrexed (Alimta) for the Treatment of Patients With Advanced Non-small Cell Lung Cancer.


Primary objective

To evaluate the overall response rate (complete plus partial responses by RECIST criteria)
to the combination of paclitaxel poliglumex and pemetrexed as therapy in patients with
advanced NSCLC.

Secondary Objectives

To evaluate the safety and adverse event profile of the combination of paclitaxel poliglumex
and pemetrexed as therapy in patients with advanced NSCLC.

To evaluate the duration of response, time to progression, and overall survival of advanced
NSCLC treated with the combination of paclitaxel poliglumex and pemetrexed.

To compare the overall response rate using three-dimensional reconstruction of target
lesions by Medical Metrx Solutions (MMS) and RECIST criteria.


Inclusion Criteria:



- Histologically or cytologically confirmed diagnosis of locally advanced and/or
metastatic NSCLC (Stage IIIB or IV).

- Bidimensionally measurable lesions or unidimensionally evaluable lesions.

- Age ≥ 18 years.

- At least one measurable target lesion as defined by Response Evaluation Criteria in
Solid Tumors (RECIST), which has not been previously treated with local therapy (e.g.
radiation therapy, chemoembolization, surgery, etc.).

- May have received prior chemotherapy (including taxanes) for advanced NSCLC.

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

- Life expectancy > 12 weeks.

- No active infections.

- Adequate liver and bone marrow function.

- AST<2.5 x ULN, bilirubin <1.5x ULN, alkaline phosphatase<2.5 x ULN (unless bone
origin and no liver metastases are documented).

- ANC ≥ 1,500/uL, platelet count ≥ 100,000/uL.

- Normal PT and PTT.

- Bisphosphates initiated prior to study entry will be permitted. However, initiation
of bisphosphonates following study entry is not permitted.

- Patients with treated brain metastases must be neurologically stable.

- At least 3 weeks since last chemotherapy and recovered from treatment-related adverse
events ≤ grade 1.

- At least 3 weeks since prior radiation and recovered from treatment-related adverse
events ≤ grade 1.

- Women of childbearing potential are eligible for the study, provided they have a
negative serum or urine pregnancy test within three days of study entry, and an
adequate method of contraception is used. Acceptable methods of birth control
include barrier methods (condoms, diaphragms with spermicide) or intrauterine devices
(IUD). Women whose sole sexual partner is infertile, or who are not sexually active,
are also eligible.

- Able to provide written informed consent.

Exclusion Criteria:

- Grade 2 or greater peripheral neuropathy, according to the National Cancer
Institute-Common Toxicity Criteria.

- Clinically significant pleural, pericardial or abdominal effusions.

- Untreated brain metastases.

- Patients with previously diagnosed brain metastases will be eligible if they are
neurologically stable and have recovered from the effects of radiotherapy or surgery
(≤ grade 2).

- Patients with brain metastases must have at least one other site of measurable
disease.

- Concurrent radiotherapy.

- Other concurrent cancer treatment-related investigational agent. Investigational
supportive care medications are permitted.

- Concurrent treatment with unfractionated heparin or warfarin.

- History of radiotherapy encompassing greater than 50% of the marrow-bearing skeleton.

- Prior bone marrow or stem cell transplant.

- History of other active malignancy within the last year requiring chemotherapy, not
including curatively-treated carcinoma in situ of the cervix, or non-melanoma skin
cancer (basal cell carcinoma or squamous cell carcinoma).

- Uncontrolled infection.

- Active bleeding, or history of bleeding requiring transfusion within 2 weeks of study
entry.

- Active cardiac disease, as defined as:

- Current history of uncontrolled or symptomatic angina.

- History of arrhythmias requiring medications or clinically significant arrhythmias,
with the exception of uncomplicated atrial fibrillation.

- Myocardial infarction < 6 months from study entry.

- Any other cardiac conditions, which in the opinion of the treating physician, would
make this protocol unreasonably hazardous for the patient.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the overall response rate (complete plus partial responses by RECIST criteria) to the combination of paclitaxel poliglumex and pemetrexed as therapy in patients with advanced NSCLC.

Outcome Time Frame:

CT or MRI scans of the chest will be obtained after every 2 cycles (6-week intervals +/- 7 days)

Safety Issue:

No

Principal Investigator

James R Rigas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Norriss Cotten Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

D-0433

NCT ID:

NCT00487669

Start Date:

October 2006

Completion Date:

November 2009

Related Keywords:

  • Advanced Non-Small Cell Lung Cancer
  • paclitaxel poliglumex
  • xyotax
  • alimta
  • advanced non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756