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Phase 2 N=21 Randomized Treatment

Carboplatin and Paclitaxel With or Without Ramucirumab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Thymic Cancer That Cannot Be Removed by Surgery

Locally Advanced Thymic Carcinoma · Metastatic Thymic Carcinoma · Recurrent Thymic Carcinoma · Unresectable Thymic Carcinoma

Enrolled (actual)
21
Serious AEs
17.7%
Results posted
Oct 2025
Primary outcome: Primary: Progression-free Survival — 8; 7 Months

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Carboplatin (Drug); Paclitaxel (Drug); Ramucirumab (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
SWOG Cancer Research Network
Primary completion
Dec 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Progression-free Survival
8; 7
SECONDARY
Frequency and Severity of Adverse Events
1; 0; 1; 0; 1; 0
SECONDARY
Response Rate
0; 0; 7; 4; 1; 6
SECONDARY
Disease Control Rate
2.92; 1.67
SECONDARY
Overall Survival
NA; NA

Summary

This randomized phase II trial studies how well carboplatin and paclitaxel with or without ramucirumab work in treating patients with thymic cancer that has spread to other places in the body, has come back, or cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as ramucirumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known if giving carboplatin and paclitaxel with or without ramucirumab will work better in treating patients with thymic cancer.

Eligibility Criteria

Inclusion Criteria

  • Patients must have histologically or cytologically confirmed thymic carcinoma; thymic carcinoma may be defined as "thymic epithelial malignancy, consistent with thymic carcinoma", or "World Health Organization (WHO) type C thymic epithelial tumor", or "thymic epithelial malignancy" with radiographic imaging consistent with thymic carcinoma
  • Patients must have unresectable thymic carcinoma, that is either locally advanced, recurrent, or metastatic
  • Patients must not be candidates for localized surgery
  • Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI) within 28 calendar days prior to randomization; the CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality; non-measurable disease must be assessed within 42 calendar days prior to randomization; all known sites of disease must be assessed and documented on the baseline tumor assessment form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
  • Patients must have a Zubrod performance status of 0 to 2
  • Patients must not have undergone major surgery within 28 calendar days prior to randomization, or minor surgery/subcutaneous venous access device placement within 7 calendar days prior to randomization; the patient must not have elective or planned major surgery to be performed during the course of the clinical trial
  • Patients must not have had prior systemic anti-cancer therapy for locally advanced or metastatic unresectable thymic carcinoma
  • If patients have recurrent unresectable thymic carcinoma, patients may have had prior neoadjuvant or adjuvant chemotherapy if treatment concluded >= 6 months prior to randomization
  • Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 calendar days prior to registration; patient must not have brain metastases unless: (1) metastases have been treated and have remained controlled for at least two weeks following treatment, AND (2) patient has no residual neurological dysfunction off corticosteroids for at least 1 day
  • Patients must not be candidates for radiation therapy with curative intent; prior palliative radiation therapy is allowed as long as a period of 7 days has passed since the last dose was received and the patient has recovered from any associated toxicity at the time of randomization
  • Absolute neutrophil count (ANC) >= 1500/mcL documented within 28 calendar days prior to randomization
  • Hemoglobin >= 9 g/dL (5.58 mmol/L) documented within 28 calendar days prior to randomization
  • Platelets >= 100, 000/mcL documented within 28 calendar days prior to randomization
  • International normalized ratio (INR) = = 40 mL/minute (that is, if serum creatinine is > 1.5 x ULN, a 24-hour urine collection to calculate creatinine clearance must be performed) documented within 28 calendar days prior to randomization
  • Patient urinary protein must be = = 2+, a 24-hour urine collection for protein must demonstrate 160 mmHg systolic or > 100 mmHg diastolic for > 4 weeks) despite standard medical management
  • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method (hormonal or barrier method of birth control; abstinence) prior to randomization, during the study participation and for 4 months after the last dose of protocol treatment; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contracepti
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03694002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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