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New combo chemo regimen shows promise in early cancer trial

NCT ID NCT01374620

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

28 people

The number who actually took part.

Started

Jul 2011

Finished

Apr 2013

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.