New combo chemo regimen shows promise in early cancer trial
NCT ID NCT01374620
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a combination of two chemotherapy drugs—weekly paclitaxel given through a vein and daily oral cyclophosphamide—in 28 adults with advanced cancer who had no other treatment options. The goal was to find the safest dose of paclitaxel when used with a fixed dose of cyclophosphamide. Researchers monitored side effects and checked if tumors shrank or stayed stable after two treatment cycles.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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28 people
The number who actually took part.
- Started
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Jul 2011
- Finished
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Apr 2013
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient with cancer histologically proved * No other therapeutic proposal after discussion in multidisciplinary consultation * Radiological evidence of the evolving nature of the disease * Measurable disease with at least one measurable lesion according to the criteria RECIST 1.1 * At least 28 days since prior treatment(systemic treatment or major surgery) * Patient who have recovered from any previous toxicity * Man or woman de ≥ 18 years and ≤ 65 years * Performance Status (ECOG) ≤ 2 within 7 days before inclusion * Polynuclear neutrophils ≥ 1500/mm3, platelets ≥ 100 000/mm3, Hemoglobin ≥ 9 g/dl * Serum Albumin ≥ 36 g/l and lymphocytes ≥ 700/mm3 * Total bilirubin and SGPT/ALT and SGOT/AST ≤ 3 ULN(≤ 5 ULN if liver metastases) * Creatinine in normal ranges and Creatinine clearance \> 60 ml/min (Cockcroft formulae) * Central venous access * Negative pregnancy test for women who may be pregnant within 7 days before inclusion * Effective contraceptive during the treatment period and up to 6 months after the end of treatment (for patients of both sexes during their reproductive and child-bearing age and their partners) * Patient covered by government health insurance * Informed consent signed by the patient before any specific study procedure Exclusion Criteria: * Prior treatment by Paclitaxel * Oral treatment impossible * Known dysphagia, malabsorption or maldigestion * Pre-existing neuropathy clinically symptomatic * Known leptomeningeal brain metastases * Known allergy to Cremophor, to Paclitaxel or one of its excipients (especially polyoxyethylene castor oil), to Cyclophosphamide or one of its excipients (lactose, sucrose) * Active and uncontrolled infection * Acute urinary tract infection, pre-existing hemorrhagic cystitis * Diabetes insipidus * History or progressive psychiatric illness * Persons under guardianship or detainees * Unable for medical follow-up (geographic, social or mental reasons) * Pregnant, or likely to be or breastfeeding women * Absence of effective contraception for the duration of treatment and 6 months after completion of therapy (for patients of both sexes in childbearing or reproductive age and their partners)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Centre Oscar Lambret
Lille, 59000, France
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Other studies related to the condition(s) this trial covers.
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