Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC

NCT ID: NCT00238615

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2014-11-30

Brief Summary

The purpose of this study is to assess how well this particular combination of chemotherapy, radiation and surgery works to help people with locally advanced lung cancer, how well PET scans indicates whether someone has responded to chemotherapy and radiation, and gene expression patterns related to outcomes in patients with locally advanced lung cancer who receive this treatment regimen.

Conditions

Lung Cancer; Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy+Radiation+Surgery

1. Concurrent weekly docetaxel at 20 mg/m2 and weekly carboplatin at an AUC of 2 with thoracic radiotherapy of 180-200cGy/day for 5/7 days to 45 Gy.

2. Complete surgical excision 3-6 weeks after completion of chemoradiotherapy.

3. No Surgery if patient is deemed unable to tolerate surgery, with completion to 61 Gy radiation

4. Consolidation after surgery: Docetaxel given at 75 mg/m2 every 3 weeks with carboplatin at AUC 6 every 3 weeks with concomitant growth factor support.

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

20 mg/m2, 75 mg/m2 infusion

Carboplatin

Intervention Type: DRUG

AUC of 2 and 6 infusion

Radiation therapy

Intervention Type: PROCEDURE

NEOADJUVANT RADIOTHERAPY Radiation therapy will be concurrent with the chemotherapy. Radiation therapy will begin within 24 hours of chemotherapy. CONSOLIDATION RADIOTHERAPY Patients with positive surgical margins or incomplete resection (tumor shaved from spine or great vessels) will receive an additional boost of radiotherapy 3 to 6 weeks after surgery. This will be a 16 Gy boost given with concurrent weekly chemotherapy as during the neoadjuvant period.

Surgical resection

Intervention Type: PROCEDURE

All patients will be taken to surgical excision, unless they have developed a condition other than progressive disease, which would make surgery unsafe.

Interventions

Docetaxel

20 mg/m2, 75 mg/m2 infusion

Intervention Type: DRUG

Carboplatin

AUC of 2 and 6 infusion

Intervention Type: DRUG

Radiation therapy

NEOADJUVANT RADIOTHERAPY Radiation therapy will be concurrent with the chemotherapy. Radiation therapy will begin within 24 hours of chemotherapy. CONSOLIDATION RADIOTHERAPY Patients with positive surgical margins or incomplete resection (tumor shaved from spine or great vessels) will receive an additional boost of radiotherapy 3 to 6 weeks after surgery. This will be a 16 Gy boost given with concurrent weekly chemotherapy as during the neoadjuvant period.

Intervention Type: PROCEDURE

Surgical resection

All patients will be taken to surgical excision, unless they have developed a condition other than progressive disease, which would make surgery unsafe.

Intervention Type: PROCEDURE

Other Intervention Names

Taxotere; Paraplatin; radiation oncology; radiotherapy; segmentectomy; segmental resection

Eligibility Criteria

Inclusion Criteria

Histologically confirmed stage IIIA or IIIB NSCLC

• Patients must have measurable disease
• No previous chemotherapy, radiation therapy or other systemic therapy for their NSCLC.
• Age>18 years
• Life expectancy >12 months
• ECOG performance status 0-1
• Normal organ and marrow function
• Medically fit for surgery at time of enrollment.
• Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study. Women must have a negative pregnancy test prior to enrollment.
• Ability to understand and willingness to sign the consent form.

Exclusion Criteria

• Previous chemotherapy, radiation therapy or any other systemic treatment for their NSCLC.
• Patients receiving any other investigational agents.
• Known metastatic disease (brain or any other site)
• History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 or with allergic reactions to compounds of similar chemical composition to carboplatin or other agents used in the study.
• Peripheral neuropathy >grade 1
• Uncontrolled concurrent illness
• Pregnant women
• Weight loss>10% in the past 3 months before diagnosis.
• Hyperglycemia - exclusion from PET analysis
• HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with docetaxel and carboplatin or other agents administered during the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aventis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Heather Wakelee

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heather A. Wakelee

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

Kozak MM, Murphy JD, Schipper ML, Donington JS, Zhou L, Whyte RI, Shrager JB, Hoang CD, Bazan J, Maxim PG, Graves EE, Diehn M, Hara WY, Quon A, Le QT, Wakelee HA, Loo BW Jr. Tumor volume as a potential imaging-based risk-stratification factor in trimodality therapy for locally advanced non-small cell lung cancer. J Thorac Oncol. 2011 May;6(5):920-6. doi: 10.1097/jto.0b013e31821517db.

Reference Type: RESULT

PMID: 21774104 (View on PubMed)

Das M, Donington JS, Murphy J, Kozak M, Eclov N, Whyte RI, Hoang CD, Zhou L, Le QT, Loo BW, Wakelee H. Results from a single institution phase II trial of concurrent docetaxel/carboplatin/radiotherapy followed by surgical resection and consolidation docetaxel/carboplatin in stage III non-small-cell lung cancer. Clin Lung Cancer. 2011 Sep;12(5):280-5. doi: 10.1016/j.cllc.2011.06.003. Epub 2011 Jul 14.

Reference Type: RESULT

PMID: 21752720 (View on PubMed)

Other Identifiers

78999

Identifier Type: OTHER

Identifier Source: secondary_id

GIA #12169

Identifier Type: OTHER

Identifier Source: secondary_id

11804

Identifier Type: OTHER

Identifier Source: secondary_id

LUN0002

Identifier Type: -

Identifier Source: org_study_id