Induction Chemotherapy Using Paclitaxel, Carboplatin, CPT-11 With Pegfilgrastim

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients enrolled on this study will have been diagnosed with non-small cell lung cancer which cannot be removed by an operation. The standard treatment for this disease is a combination of chemotherapy and radiation therapy; however, the best way to combine these treatments is not known. This study will examine if the combination of chemotherapy and radiotherapy has an increased effect on slowing tumor growth with the addition of a drug called ZD1839.

In this study, chemotherapy will be given initially (induction therapy) to try to control the spread of the cancer. Then radiation and chemotherapy will be given together. Receiving chemotherapy at the same time as radiation treatments can enhance the effect of the radiation. In this study, patients will receive a drug called ZD1839. In laboratory tests on cancer cells, ZD1839 has shown an additive effect when used in combination with radiation. ZD1839 has also been shown to slow or stop growth in tumors.

The purpose of this study is to determine the side effects and effectiveness of using ZD1839 when used with radiation in this treatment regimen (induction chemotherapy followed by combination chemotherapy, ZD1839, and radiation therapy).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: Amgen; AstraZeneca
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Irinotecan; Paclitaxel

Criteria

Inclusion Criteria:

1. Subjects 18 years of age or older.

2. Subjects with histologically or cytologically confirmed NSCLC that is considered generally unresectable or inoperable. No prior chemotherapy for NSCLC or thoracic radiotherapy is allowed.

3. Subjects with Stage IIIA or IIIB disease (clinically or surgically staged).

4. Subject with disease designated T3, N0-N1 based on mediastinal invasion or proximity to the carina.

Subjects with contralateral mediastinal disease (N3) are eligible if all gross disease can be encompassed within the radiation port.

5. Subjects with pleural fluid that is a transudate and is cytologically negative.

6. Subjects with pleural effusions that are seen only on CT scan and are too small to tap.

7. Subjects with measurable or evaluable disease.

8. Subjects with PS of 0 or 1 by the ECOG scale (see Appendix 2).

9. Subjects with laboratory values as follows:

Absolute granulocyte count: ≥1,500/µL Platelets: ≥100,000/µL Total bilirubin: ≤1.5 x institutional upper normal limit Serum creatinine: <1.6 mg/dL or Creatinine clearance:>40 mL/min

AST and ALT: ≤2.5 x institutional upper normal limit FEV 1 >800 cc

10. Subjects must be nonpregnant and non-lactating. Subjects of childbearing potential must implement an effective method of contraception during the study. All female subjects, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.

11. Subjects must have a life expectancy > 2 months.

12. Subjects must be seen by both a medical oncologist and a radiation oncologist before registration.

13. Subjects must be informed of the investigational nature of the study and must sign an informed consent form.

Exclusion Criteria:

1. Subjects with disease designated T3, N0-N1 based on chest wall invasion, subjects with N3 supraclavicular disease, or subjects with superior sulcus tumors.

2. Subjects with cytologically positive pleural effusions.

3. Subjects who have received prior chemotherapy or radiochemotherapy for lung cancer or prior chest radiotherapy.

4. Subjects who are < 3 weeks since formal exploratory thoracotomy.

5. Subjects with a history of other cancers except in situ carcinoma of the cervix or breast, inactive nonmelanomatous skin cancer, or other cancer, unless the subject has been free of disease for > 5 years.

Also, exceptions can be made by the PI for a subject with a malignancy for which the prognosis is substantially better than the subject's prognosis for NSCLC.

6. Subjects with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment. Subjects with post-obstructive pneumonia remain eligible.

7. Subjects with dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.

8. Pregnant or breast-feeding females or subjects not using adequate methods of birth control.

9. Subjects receiving other investigational therapy or non-approved therapy within 30 days before Day 1 of protocol treatment.

10. Subjects with known hypersensitivity to E coli-derived proteins, pegfilgrastim, or any component of the product will be excluded.

11. Subjects with metastatic disease are excluded.

12. Subjects taking phenytoin, rifampicin, barbiturates, carbamazepine, or St. John's Wort.

13. Any evidence of clinically active ILD (subjects with chronic stable radiographic changes who are asymptomatic need not be excluded).

14. Subjects with evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.

15. As judged by the investigator, subjects with any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).

16. Subjects with known severe hypersensitivity to ZD1839 or any of the excipients of this product.