At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed stage IV or recurrent adenocarcinoma of the breast
- ✓Measurable disease
- ✓ECOG 0-2 OR Karnofsky 60-100%
- ✓Age 18 and over
- ✕Disease recurrence within 1 year of prior adjuvant docetaxel
- ✕Prior chemotherapy for recurrent or metastatic disease
- ✕Prior severe hypersensitivity reaction to docetaxel or drugs formulated with polysorbate 80
- ✕Peripheral neuropathy greater than grade 1
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study Of The Weekly Administration Of Docetaxel In Combination With The Epidermal Growth Factor Receptor Inhibitor OSI-774 In Recurrent And/Or Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating docetaxel and erlotinib hydrochloride for Breast Cancer. Completed, enrolled 39 participants across 1 site.
Detailed Summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with docetaxel may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining erlotinib with docetaxel in treating patients who have stage IV or recurrent breast cancer.
Study Details
Timeline
Interventions
Docetaxel IV infusion weekly for 3 weeks with a one-week break. One cycle is 4 weeks (28 days). Patients' actual weight will be used to calculate dose.
OSI-774 will be taken 1 hour before or 2 hours after meals. Cycle 1 will be administered at dose level -1.If no grade 3 or 4 toxicity occurs during cycle 1, then the patient may proceed to be treated at dose level 0 for the remaining chemotherapy cycles.