Phase 1
Completed N=68
Phase I Imaging Study Evaluating Gem/Cis or Gem/Carbo for Participants With Non-Small Cell Lung Cancer (MK-0000-083 AM3)
Carcinoma · Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00599755 ↗
Enrolled (actual)
68
Serious AEs
35.3%
Results posted
Jun 2012
Primary outcomePrimary: Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean — 10 Participants
Summary
This study will use imaging to look at tumor response to combination chemotherapy of gemcitabine (Gem) and cisplatin (Cis) or gemcitabine and carboplatin (Carbo) in non small cell lung cancer (NSCLC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Metabolic Response Conversion Rate Between 3 and 6 Weeks After Starting Chemotherapy at a Threshold of a 20% Decrease in SUVmean |
10 | — |
| SECONDARY Repeatability of FDG SUVmean at Baseline |
3.79 | — |
| SECONDARY Change in FDG-PET Uptake From Baseline to Week 3 |
0.75 | — |
| SECONDARY Change in FDG-PET Uptake From Week 3 to Week 6 |
0.85 | — |
| SECONDARY Change in FGD-PET Uptake From Baseline to Week 6 |
0.65 | — |
Eligibility Criteria
Inclusion Criteria
- Has histologically or cytopathologically confirmed metastatic or locally advanced stage IIIB/IV Non-small cell lung cancer (NSCLC)
- Has measurable disease
- Has not been previously treated with surgery (involving the thorax), radiation (unless it was for a metastatic site), or chemotherapy for NSCLC
- Is 18 years of age or older
- Has a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
- Women of childbearing potential have a negative pregnancy test
Exclusion Criteria
- Is participating in or has participated in a study with an investigational compound or device within 30 days or 5 half-lives of the start of treatment
- Has untreated brain metastases related to their NSCLC or carcinomatous meningitis
- Abuses drugs or alcohol
- Is pregnant or breastfeeding
- Is Human Immunodeficiency Virus (HIV) positive
- Has active viral hepatitis
- Has hearing loss
- Has poorly controlled diabetes mellitus
- Is allergic to gemcitabine, cisplatin or carboplatin
Data sourced from ClinicalTrials.gov (NCT00599755). 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. Informational only — not medical advice.