Clinical trial · Interventional
ABI-007 in Treating Patients With Persistent or Recurrent Cervical Cancer
A Phase II Evaluation of ABI-007 in the Treatment of Persistent or Recurrent Squamous or Nonsquamous Cell Carcinoma of the Cervix
NCT00309959CI-TRIAL-00036388completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial is studying how well ABI-007 works in treating patients with persistent or recurrent cervical cancer. Drugs used in chemotherapy, such as ABI-007, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Conditions
Conditions (5)
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 Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Cervical Adenosquamous Carcinoma | Cervical Adenosquamous Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cervical Small Cell Carcinoma | Cervical Small Cell Neuroendocrine Carcinoma | ALIAS | 0.90 |
| Cervical Squamous Cell Carcinoma | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
| Recurrent Cervical Carcinoma | Cervical Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Paclitaxel Albumin-Stabilized Nanoparticle Formulation | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (paclitaxel albumin-stabilized nanoparticle)
- description
- Patients receive ABI-007 IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
- Other: Laboratory Biomarker Analysis
Primary outcomes (2)
- measure
- Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
- timeFrame
- CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months until disease progression for up to 5 years.
- description
- RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Persistent or recurrent squamous or nonsquamous cell carcinoma of the cervix with documented disease progression * Histologic confirmation of the original primary tumor * Measurable disease, defined as at least one target lesion that can be accurately measured in at least one dimension ≥ 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT scan, or MRI, or ≥ 10 mm when measured by spiral CT scan * Tumors within a previously irradiated field will be designated as nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days after completion of radiotherapy * Must have received 1 prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent squamous or nonsquamous cell carcinoma of the cervix * Chemotherapy administered as a radiosensitizer is not a systemic chemotherapy regimen * Not eligible for a higher priority GOG protocol * GOG performance status 0, 1, or 2 * No active infection requiring antibiotics * Platelet count ≥ 100,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * SGOT and alkaline phosphatase ≤ 2.5 times ULN * No neuropathy (sensory and motor) \> grade 1 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No evidence of any other invasive malignancies within the past 3-5 years, except localized breast cancer, head and neck cancer, cervical cancer, or nonmelanoma skin cancer * No pre-existing hearing loss/tinnitus \> grade 1 * No concurrent amifostine or other protective agents * Recovered from effects of prior surgery, radiotherapy, or chemotherapy * Hormonal therapy directed at malignant tumor must be discontinued at least 1 week prior to study entry * Continuation of hormone replacement therapy permitted * At least 3 weeks since prior biological therapy and immunotherapy * No more than 1 prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy) * May have received 1 additional noncytotoxic (biologic or cytostatic) regimen, including monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction * No prior radiotherapy to any portion of the abdominal cavity or pelvis * Radiotherapy for the treatment of cervical cancer within the past 5 years allowed * Radiotherapy for localized breast cancer, head and neck or skin allowed provided completion \> 3 years prior to study entry and remains free of recurrent or metastatic disease * No prior chemotherapy for any abdominal or pelvic tumor * Chemotherapy for the treatment of cervical cancer within the past 5 years allowed * Prior adjuvant chemotherapy for localized breast cancer provided completion \> 3 years prior to study entry and remains free of recurrent or metastatic disease * No prior therapy with ABI-007 or any other taxane * No prior anticancer treatment that would preclude study therapy * No concurrent ritonavir, saquinavir, indinavir, nelfinavir, or anticonvulsants
References
Publications (0)
Data not yet available
No reference posted for this study.