Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may make tumor cells more sensitive to radiation therapy. Giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel albumin-stabilized nanoparticle formulation together with radiation therapy and erlotinib works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jan 31, 2018 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Drug: carboplatin; Drug: erlotinib hydrochloride; Drug: paclitaxel albumin-stabilized nanoparticle formulation; Radiation: radiation therapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologies:
- Squamous cell carcinoma
- Adenocarcinoma (including bronchoalveolar cell)
- Large cell anaplastic carcinoma (including giant and clear cell carcinomas)
- Must meet the following criteria:
- T1-3 with N2 and selected N3\
- T4 with N0, N1, N2 and selected N3\
- M0 (no M1 patients) NOTE: \*Patients with contralateral mediastinal disease (i.e., N3) are eligible, provided all gross disease can be encompassed within the radiation boost field in accordance with the homogeneity criteria. Patients with ipsilateral scalene or supraclavicular disease are also eligible. Patients with contralateral hilar or supraclavicular node involvement are not eligible.
- Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- Nonmeasurable lesions include the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural or pericardial effusion
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Tumor lesions situated in a previously irradiated area
- Patients must be considered unresectable or inoperable AND be deemed candidates for combined modality therapy by a medical oncologist and a radiation oncologist
- Considered to be poor-risk with NCI CTC performance status (PS) 2 OR PS 0-1 and ≥ 10% weight loss within the past 3 months
- Patients with tumors adjacent to a vertebral body are eligible, provided all gross disease can be encompassed within the radiation boost field in accordance with the homogeneity criteria
- Pleural effusions meeting the following criteria allowed:
- Effusion is transudate, cytologically negative, and non-bloody
- Effusion can be seen on the chest CT scan but not on the chest x-ray AND is too small to tap
- Effusion appears only after a thoracotomy or other invasive thoracic procedure was attempted PATIENT CHARACTERISTICS:
- See Disease Characteristics
- Granulocytes ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Creatinine ≤ 1.5 x upper limit of normal (ULN)
- AST \< 2 x ULN
- Bilirubin ≤ ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy for NSCLC
- At least 2 weeks since formal exploratory thoracotomy
- No concurrent administration of sucralfate suspension and erlotinib hydrochloride
- No concurrent intensity-modulated radiotherapy
- No concurrent hormones or other chemotherapeutic agents except steroids given for adrenal failure, hormones administered for non-disease-related conditions (e.g., insulin for diabetes), and intermittent use of dexamethasone as an antiemetic
- No concurrent palliative radiotherapy
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- East Bay Radiation Oncology CenterCastro Valley, California
- Valley Medical Oncology Consultants - Castro ValleyCastro Valley, California
- Valley Medical OncologyFremont, California
- Contra Costa Regional Medical CenterMartinez, California
- Camino Medical Group - Treatment CenterMountain View, California
- El Camino Hospital Cancer CenterMountain View, California
- Highland General HospitalOakland, California
- Alta Bates Summit Medical Center - Summit CampusOakland, California
- Bay Area Breast Surgeons, IncorporatedOakland, California
- CCOP - Bay Area Tumor InstituteOakland, California
- Larry G Strieff MD Medical CorporationOakland, California
- Tom K Lee, IncorporatedOakland, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 31, 2018. Always confirm current availability with the study team.