Clinical trial · Interventional
Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent Cervical Cancer
A Phase II Trial of Chemosensitization With Paclitaxel, 13-cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual and lack of study drug
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving isotretinoin and interferon alpha-2b together with paclitaxel may reduce drug resistance and allow the tumor cells to be killed. PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alpha-2b together with paclitaxel works in treating patients with stage IV, recurrent, or persistent cervical cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| isotretinoin | Drug | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| recombinant interferon alpha-2b | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
- description
- * Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle * Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle * Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days
- interventionNames
- Biological: recombinant interferon alpha-2b
- Drug: isotretinoin
- Drug: paclitaxel
Primary outcomes (1)
- measure
- Response Rate (Complete and Partial)
- timeFrame
- 8 years
- description
- All patients who receive at least 3 courses of protocol therapy will be considered evaluable for response of measurable disease.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically and/or cytologically confirmed cervical cancer, meeting 1 of the following criteria: * Stage IVB disease * Recurrent disease * Persistent disease * Patients previously treated with chemoradiotherapy as initial therapy must demonstrate disease progression * Measurable disease by physical exam or radiographic studies * Not amenable to chemoradiotherapy or surgery PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-2 Life expectancy * At least 6 months Hematopoietic * WBC ≥ 3,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * SGOT and SGPT ≤ 2 times upper limit of normal * Bilirubin ≤ 1.5 mg/dL Renal * Creatinine ≤ 1.5 mg/dL OR * Creatinine clearance ≥ 50 mL/min Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known HIV positivity * No active infection * No medical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * No prior interferon * No other concurrent immunotherapy Chemotherapy * See Disease Characteristics * At least 3 months since prior chemoradiotherapy (6 weeks for patients experiencing disease progression after completion of initial chemoradiotherapy) * No other prior chemotherapy Endocrine therapy * No concurrent hormonal therapy for cancer Radiotherapy * See Disease Characteristics * See Chemotherapy * Recovered from prior radiotherapy * No concurrent radiotherapy Surgery * Recovered from prior surgery * No concurrent surgery for cancer Other * No prior retinoids * No other concurrent anticancer therapy * No other concurrent experimental agents
References
Publications (0)
Data not yet available