TriangleNCT03943667 · CITED IN SOURCE DOCUMENTS
Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2026-01-15
This study aims to evaluate whether the combination of gemcitabine and paclitaxel allows to improve the overall survival compared to gemcitabine alone, in patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC) after FOLFIRINOX failure or intolerance.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Metastatic Pancreatic Ductal Adenocarcinoma with histological or cytological proof * Age ≥18 years * At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 outside any previously irradiated area * Failure of first line FOLFIRINOX (Progressive disease during therapy of within 3 months +/- 15 days) * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 * Life expectancy ≥12 weeks * Negative serology (HIV, hepatitis B and C) * Adequate organs function * Proven Post-menopausal status or negative urinary or serum pregnancy test * Woman of childbearing potential and male patients must agree to use adequate contraception fo the duration of the trial and up to 6 months after completing treatment * Patients affiliated to the social security system * Patient must have signed a written informed consent form Exclusion Criteria: * Any other primary tumor or secondary malignancy except basal cell carcinoma of skin or in situ carcinoma of the cervix uteri * Known cerebral metastasis * Uncontrolled severe infections * Patients with Kaposi's sarcoma * Peripheral neuropathy exceeding grade 2 on Common Terminology Criteria for Adverse Events (CTCAE) v5.0 * Previous treatment with taxane and/or gemcitabine (for pancreas cancer only) * Patients with known allergy or severe hypersensitivity to any trial drug or drug excipient * Patients with any other disease or illness which requires hospitalisation or is incompatible with the trial treatment * Patients unable to comply with trial obligations for geographic, social or physical reasons, or who are unable to understand the purpose and procedures of the trial * Participation in another clinical trial within 14 days prior to randomization * Patients deprived of liberty or under legal protection measures or patients whose willingness to participate in the trial may be unduly influenced
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Gemcitabine + Paclitaxel until progression
- intervention Names
- Drug: Gemcitabine
- Drug: Paclitaxel
- label
- GEMPAX
- type
- EXPERIMENTAL
- description
- Gemcitabine alone until progression
- intervention Names
- Drug: Gemcitabine
- label
- Control
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Control
- GEMPAX
- description
- 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
- name
- Gemcitabine
- other Names
- GEMZAR
- type
- DRUG
- arm Group Labels
- GEMPAX
- description
- 80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.
- name
- Paclitaxel
- other Names
- TAXOL
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 211
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Time from the date of randomization to the date of death from any cause
- measure
- Overall Survival
- time Frame
- Until death (life expectancy around 12 months)
Full study description
- brief Summary
- This study aims to evaluate whether the combination of gemcitabine and paclitaxel allows to improve the overall survival compared to gemcitabine alone, in patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC) after FOLFIRINOX failure or intolerance.
Source references
- references
- citation
- Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
- pmid
- 21561347
- type
- BACKGROUND
- citation
- De La Fouchardiere C, Malka D, Cropet C, Chabaud S, Raimbourg J, Botsen D, Launay S, Evesque L, Vienot A, Perrier H, Jary M, Rinaldi Y, Coutzac C, Bachet JB, Neuzillet C, Williet N, Desgrippes R, Grainville T, Aparicio T, Peytier A, Lecomte T, Roth GS, Thirot-Bidault A, Lachaux N, Bouche O, Ghiringhelli F. Gemcitabine and Paclitaxel Versus Gemcitabine Alone After 5-Fluorouracil, Oxaliplatin, and Irinotecan in Metastatic Pancreatic Adenocarcinoma: A Randomized Phase III PRODIGE 65-UCGI 36-GEMPAX UNICANCER Study. J Clin Oncol. 2024 Mar 20;42(9):1055-1066. doi: 10.1200/JCO.23.00795. Epub 2024 Jan 17.
- pmid
- 38232341
- type
- DERIVED
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
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- occurrences
- context exact
- div></li><li>Gemcitabine/paclitaxel versus gemcitabine after FOLFIRINOX failure or intolerance: The prospective, open-label, phase III <a href="/clinicaltrials/NCT03943667">GEMPAX</a> study (NCT03943667) included 211 patients with metastatic pancreatic cancer that progressed during or within 3 months of completing first-line FOLF
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- context exact
- axel versus gemcitabine after FOLFIRINOX failure or intolerance: The prospective, open-label, phase III <a href="/clinicaltrials/NCT03943667">GEMPAX</a> study (NCT03943667) included 211 patients with metastatic pancreatic cancer that progressed during or within 3 months of completing first-line FOLFIRINOX (including FOLFIRINOX tr
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- source retrieved at
- 2026-09-09T23:22:11.084713+00:00
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- source title
- Pancreatic Cancer Treatment (PDQ®)–Health Professional Version
- source update dates
- context
- Updated: February 12, 2025
- datetime
- 2025-02-12T12:00:00Z
- display
- February 12, 2025
Preserved source evidence · Not medical advice