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Phase II Study of Combination of Paclitaxel Poliglumex and Alimta for Advanced Non-small Cell Lung Cancer (NSCLC)

Information source: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Advanced Non-small Cell Lung Cancer

Intervention: paclitaxel poliglumex, pemetrexed (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Dartmouth-Hitchcock Medical Center

Official(s) and/or principal investigator(s):
James R Rigas, MD, Principal Investigator, Affiliation: Norriss Cotten Cancer Center

Summary

This is a non-randomized, single-arm, single-institution, open label, two-stage phase II and dose-ranging study designed to evaluate the efficacy and safety of paclitaxel poliglumex in combination with pemetrexed in patients with advanced stage IIIB or stage IV NSCLC.

Clinical Details

Official title: 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.

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

Primary outcome: 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 outcome:

Time to Progression

Overall Survival

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States
Additional Information

Norris Cotton Cancer Center Home Page

Starting date: October 2006
Last updated: November 21, 2013

Page last updated: August 20, 2015

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