Clinical trial · Interventional
Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Gynecological Cancer Patients
A Phase I Trial of Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Recurrent or Refractory Gynecological Cancer Patients
NCT00268918CI-TRIAL-00034022completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study is to see if the study drug, PTK787, is safe and to find the highest dose that can be given safely without causing serious side effects.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Docetaxel / PTK787
- description
- Docetaxel: Lead In: Given intravenously on Day 1 and Day 14 Afer Lead in: Given intravenously on day 1, 8, 15, 22 of each 28-day cycle. PTK787: Lead In: Given orally on day 4 and day 14 After Lead In: Given orally once a day.
- interventionNames
- Drug: Docetaxel
- Drug: PTK787
Primary outcomes (1)
- measure
- To determine the maximum tolerated dose and the dose limiting toxicity of weekly Taxotere patients treated with PTK787.
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- To estimate the preliminary efficacy of this combination in both metastatic breast cancer patients and refractory gynecological patients.
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Recurrent gynecological cancers or metastatic breast cancer. Initial diagnosis must be confirmed histologically. * Measurable disease or nonmeasurable disease * Age \> 18 years * ECOG performance 0,1,2 * 4 weeks or greater since major surgery, 3 weeks or greater since chemotherapy * Certain lab values * Negative for proteinuria Exclusion Criteria: * Four or more treatment regimens * History or presence of uncontrolled CNS disease * Prior biologic or immunotherapies less than 3 weeks prior to registration * Prior full field radiotherapy less than 4 weeks or limited field radiotherapy less than 2 weeks prior to registration * Prior therapy with anti-VEGF agents * Peripheral neuropathy with functional impairment \> CTC grade 2 * Pregnant or breast feeding * Concurrent severe and/or uncontrolled medical condition * Chronic renal disease * Acute or chronic liver disease * Impairment of gastrointestinal function or GI disease * Confirmed diagnosis of HIV infection are excluded at the investigators discretion * Therapeutic warfarin sodium or similar oral anticoagulants that are metabolized by the cytochrome p450 system.
References
Publications (0)
Data not yet available
No reference posted for this study.