Phase 2
N=399
Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer
Lung Cancer, Non-Small Cell · Non-Small-Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00065182 ↗Enrolled (actual)
399
Serious AEs
27.1%
Results posted
Jun 2019
Primary outcome: Primary: Median Time of Overall Survival — 30.7; 28.6 Weeks — p=0.9460
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Topotecan/Docetaxel combination (Drug); Docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Time of Overall Survival |
30.7; 28.6 | 0.9460 |
| SECONDARY Number of Participants With One-year Survival |
— | — |
| SECONDARY Median Time to Progression |
— | — |
| SECONDARY Response Rate |
— | — |
| SECONDARY Response Duration |
— | — |
| SECONDARY Time to Response-assessed Every 8 Weeks |
— | — |
| SECONDARY Assessment of Quality of Life-assessed Every 4 Weeks |
— | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
186; 172; 58; 49 | — |
| SECONDARY Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities |
76; 107; 95; 46; 18; 11 | — |
| SECONDARY Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities |
3; 3; 4; 2; 0; 1 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormal Vital Signs Data |
0; 0 | — |
Summary
The purpose of this study is to compare the efficacy and safety of a weekly regimen of two FDA approved drugs in combination versus one FDA approved drug in subjects with advanced non-small cell lung cancer who have received one previous chemotherapy excluding TAXOTERE or HYCAMTIN.
Eligibility Criteria
Inclusion criteria
- Written informed consent
- At least 18 years old
- Confirmed advanced non-small cell lung carcinoma (NSCLC)
- Received one prior chemotherapy for metastatic NSCLC excluding TAXOTERE or HYCAMTIN. In addition, subjects are allowed to have previously received a non-cytotoxic therapy, such as an endothelial growth factor receptor (EGFR) or angiogenesis inhibitor.
- Presence of either measurable or non-measurable disease by radiologic study or physical examination.
- Full recovery and at least 21 days from prior treatment for NSCLC; 42 days from treatment with mitomycin or nitrosureas and 30 days from prior non-cytotoxic therapy.
- At least 3 weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the patient).
- At least 7 days since prior radiotherapy.
- A probable life expectance of at least 3 months.
- Adequate bone marrow reserve, CBC/Platelet, kidney and liver function.
Exclusion criteria
- Concomitant malignancies or other malignancies within the last five years.
- Symptoms of brain metastases requiring treatment with steroids.
- Active infection.
- Severe medical problems other than the diagnosis of NSCLC that would limit the ability of the subject to follow study guidelines or expose the subject to extreme risk.
- Ongoing or planned chemotherapy (other than treatment during this study), immunotherapy, radiotherapy, or investigational therapy for the treatment of NSCLC.
- Use of investigational drug within 30 days or 5 half-lives prior to the first dose of study medication.
- Women who are pregnant or lactating.
- Subjects of child-bearing potential refusing to practice adequate contraception.
- Prior treatment with or history of allergic reaction to either HYCAMTIN or TAXOTERE.
- Subjects who cannot receive steroid premedication.
Data sourced from ClinicalTrials.gov (NCT00065182). 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.