A phase II clinical trial involving the use of low-dose daily oral cyclophosphamide, weekly vinblastine and rofecoxib in patients with advanced solid tumors
Bibliographic record
Abstract
3137 Background: Preclinical studies indicate the conventional chemotherapeutic agents given continuously at low doses may provide an improved therapeutic index (RS Kerbel et al, Annals of Oncology 13:12–15, 2002). Cyclophosphamide and vinblastine have been best studied in experimental models where tumor growth retardation is achieved, at least in part, through antiangiogenic mechanisms. Methods: 50 with advanced solid tumors were enrolled (26 male and 24 female, median age 63 years - range 24 - 85). 43 patients had received at least one prior chemotherapy regimen. Patients were required to have ECOG performance status < 2, a life expectancy of > 3 months and at least one measurable lesion. All patients received cyclophosphamide 50 mg PO daily, weekly injections of vinblastine 3 mg/m2, and rofecoxib 25 mg PO daily. Results: Of the 45 evaluable patients, there were 2 complete responses (CR) (4%), 4 partial responses (PR) (9%) for an overall objective response rate of 13%. An additional 6 patients achieved disease stabilization (SD) ≥ 6 months (13%). The primary endpoint of clinical benefit (CR + PR + SD ≥ 6 months) was, therefore, 26%. The median progression-free survival for all patients was 105 days, and 240 days for patients experiencing clinical benefit. The incidence of grade 3/4 toxicities were as follows: neutropenia 12/2, anaemia 2/0, and thrombocytopenia 1/0. No patients developed grade 3 or 4 nausea, vomiting, mucositis or alopecia. Conclusions: This low-dose regimen consisting of daily oral cyclophosphamide and weekly vinblastine injections given concurrently with rofecoxib is associated with minimal toxicity and provides significant clinical benefit to patients with advanced solid tumors. These results are particularly encouraging given the nature of the study population, and indicate that this regimen merits further investigation in specific disease site studies. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration This clinical research was supported only by the Northern Cancer Research Foundation - a non-profit, regional charitable organization. No personal income was included in this support.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".