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Phase I Dose Escalation Trial of Proton Beam Radiotherapy With Concurrent Chemotherapy and Nelfinavir for Inoperable Stage III NSCLC


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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Trial Information

Phase I Dose Escalation Trial of Proton Beam Radiotherapy With Concurrent Chemotherapy and Nelfinavir for Inoperable Stage III NSCLC


Overall objectives:

1. Determine MTD of proton beam radiotherapy with concurrent cisplatin and etoposide for
stage III NSCLC.

2. Determine MTD of proton beam radiotherapy with concurrent carboplatin and paclitaxel
for stage III NSCLC in non-cisplatin candidates.

3. Determine MTD of Nelfinavir with concurrent chemoradiotherapy for stage III NSCLC at
RPTD of proton beam radiotherapy.

4. Develop biomarker for clinical outcome with concurrent chemoradiotherapy in stage III
NSCLC.

5. To determine clinical efficacy, as defined by metabolic response, sites of recurrence
(e.g., local, regional, distant) and progression-free and overall survival.


Inclusion Criteria:



1. Histologically confirmed diagnosis of NSCLC.

2. Stage IIIA or IIIB NSCLC.

3. Patients must have no evidence of metastatic disease based on routine imaging.

4. Patients must have a Karnofsky Performance Status of 60.

5. Age 18 and older.

6. Patients must be able to provide informed consent.

7. Adequate bone marrow function (i.e. WBC larger than or equal to 4000/mm3, platelets
larger than or equal to 100,000 mm3).

8. Adequate renal function for cisplatin or carboplatin as determined by the medical
oncologist: Usually Calculated creatinine clearance (CrCl) larger than or equal to 45
mL/min or serum creatinine level smaller than or equal to1.5 x institutional ULN.

9. Patients must have bilirubin 1.5 mg/dl.

10. Women of child-bearing potential as long as she agrees to use a recognized method of
birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc).

11. Hysterectomy or menopause must be clinically documented.

Exclusion Criteria:

1. Prior or simultaneous malignancies within the past two years (other than cutaneous
squamous or basal cell carcinoma or melanoma in situ).

2. Pregnant women, women planning to become pregnant and women that are nursing.

3. Actively being treated on any other research study.

4. For the Nelfinavir phase of the trial only: Patients who are taking Antiarrhythmics
(amiodarone, quinidine), Antimycobacterial (rifampin), Ergot Derivatives
(dihydroergotamine, ergonovine, ergotamine, ethylergonovine), Herbal Products (St.
John's wort/ hypericum perforatum), HMG-CoA Reductase Inhibitors (lovastatin,
simvastatin), Neuroleptic (pimozide), Proton Pump Inhibitors, or Sedative/ Hypnotics
(midazolam, triazolam). Note: Patients with the following conditions are deemed
unsuitable for cisplatin-based chemotherapy (and will be treated with carboplatin):
(a) Hearing impairment/ peripheral neuropathy Grade 1 or less at baseline (b)
Symptomatic/uncontrolled congestive heart failure (unable to tolerate volume load
with pre- and post-cisplatin hydration)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Outcome Measure:

Feasibility

Outcome Description:

Feasibility will be based on multiple radiation planning and treatment parameters.Treatment will be deemed infeasible if patient cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised. Patient is unable to tolerate 30% of treatments using proton radiotherapy, that is, up to 70% of treatments could be delivered using photons. Patient is unable to complete all of his/her treatments within 10 days of estimated date of treatment completion or require a treatment break greater than 5 days.

Outcome Time Frame:

10 days of estimated date of treatment completion or requires a treatment break greater than 5 days

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

UPCC 01510

NCT ID:

NCT01108666

Start Date:

March 2010

Completion Date:

Related Keywords:

  • Non Small Cell Lung Cancer
  • Adult subjects with a confirmed diagnosis of Stage IIIA or IIIB NSCLC, with adequate bone marrow, liver and renal function.
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283