Phase 2
N=30
Bendamustine With Irinotecan Followed by Etoposide/Carboplatin for Patients With Extensive Stage Small Cell Lung Cancer
Small Cell Lung Cancer · Extensive Stage Lung Cancer · Chemonaive
Bottom Line
View on ClinicalTrials.gov: NCT00856830 ↗Enrolled (actual)
30
Serious AEs
50.0%
Results posted
Jul 2017
Primary outcome: Primary: Number of Participants Experiencing Dose Limiting Toxicity Regimen A - Phase I — 0; 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Novel Drug Combination (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Dose Limiting Toxicity Regimen A - Phase I |
0; 1; 1 | — |
| PRIMARY Number of Patients With Adverse Events - Phase II |
8 | — |
| SECONDARY Progression Free Survival |
6.0 | — |
Summary
Small cell lung cancer, or SCLC, constitutes approximately 15% of the 170,000 new cases of lung cancer diagnosed annually in the United States. Extensive-stage SCLC comprises two thirds of new cases and is generally considered sensitive to chemotherapy, despite a median time to progression of 4 months. SCLC is one of the most aggressive and lethal types of cancer, with a median survival of 9 months (range 7-11 months) in patients diagnosed with extensive disease. Overall, the majority of patients with SCLC die in less than 2 years (2-year survival rates generally less than 10%), and the 5-year survival rate is 2.3% for patients with extensive disease. The regimen of etoposide in combination with a platinum (cisplatin or carboplatin) is generally considered the "standard of care" although a recent Phase III trial suggests improved survival with the combination of cisplatin/irinotecan. Further evaluation of new agents in combination regimens attempting to overcome the intrinsic drug resistance seen in extensive-stage SCLC is warranted attempting to improve survival and achieve palliation of disease-related symptoms.
Eligibility Criteria
Inclusion Criteria
- Histologic or cytologic diagnosis of extensive stage SCLC.
- Measurable or assessable tumor parameters.
- ECOG Performance Status 0-2.
- Age between 18 and 79 years (in the State of Alabama > 18).
- Adequate bone marrow, liver and renal function, defined as:
- Absolute neutrophil count (ANC) ≥ 1500/µL
- Hemoglobin ≥ 8g/dl
- Platelet count ≥ 100,000/µL
- SGOT/SGPT ≤ 2 x upper limit of normal or ≤ 5 x upper limit of normal when liver metastases are present.
- Total bilirubin value ≤ 2 x upper limit of normal.
- Serum creatinine value ≤ 2 x upper limit of normal.
- Fully recovered from any previous surgery (at least 4 weeks since major surgery)
- Must have recovered from prior radiation therapy (at least 3 weeks)
- All subjects must agree to practice approved methods of birth control (if applicable). A negative pregnancy test must be documented during the screening period for women of childbearing potential.
- Must provide written informed consent and authorization to use and disclose health information (HIPAA).
- Extensive-stage SCLC as defined as disease not confined to one hemithorax, including ipsilateral pleural effusion or pericardial effusion.
- No prior chemotherapy.
Exclusion Criteria
- Concurrent cancer chemotherapy, biologic therapy or radiotherapy.
- Administration of any investigational drug within 28 days prior to administration of the current therapy.
- Symptomatic brain metastases; those patients should be treated first with either whole brain radiation therapy or radiosurgery.
- Concurrent serious infection.
- Concomitant severe or uncontrolled underlying medical disease unrelated to the tumor, which is likely to compromise patient safety and affect the outcome of the study.
- History of other malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for a minimum of 2 years.
- Neuropathy at baseline ≥ Grade 2.
- Any evidence or history of hypersensitivity or other contraindications for the drugs used in this trial.
- History of chronic diarrhea; or diarrhea (excess of 2-3 stools/day above normal frequency) in the past 2 weeks.
- History of a positive serology for human immunodeficiency virus (HIV).
- Psychiatric disorder that prevents patients from providing informed consent or following protocol instructions.
- Pregnant or lactating women.
Data sourced from ClinicalTrials.gov (NCT00856830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.